Table And Attachments, Operating-room
General, Plastic Surgery · 21 CFR 878.4950
Recent MDR events
223 adverse event reports on file
- NAJul 27, 2026InjurySteris Corporation1043572-2026-00071
- ADAPTABLE BEACH CHAIRJul 7, 2026MalfunctionQuantum Ops, Inc.3019856155-2026-00003
- ADAPTABLE BEACH CHAIRJul 7, 2026MalfunctionQuantum Ops, Inc3019385615-2026-00001
- ADAPTABLE BEACH CHAIRJul 7, 2026MalfunctionQuantum Ops, Inc.3019856155-2026-00002
- MIOJun 11, 2026MalfunctionUs Endoscopy1528319-2026-00067
- LEG HOLDERApr 9, 2026MalfunctionMaquet Gmbh8010652-2026-0000034
- NAJan 28, 2026MalfunctionSteris Corporation1043572-2026-00013
- ACCESSORIES UNIVERSALDec 30, 2025MalfunctionMaquet (suzhou) Co.,ltd.3007417753-2025-000000
- TRIMANO FORTIS REUSABLE LEG HOLDERDec 1, 2025MalfunctionArthrex, Inc.1220246-2025-05243
- PAD 30 MM FOR 1180.16A1, F1Oct 24, 2025InjuryMaquet Gmbh8010652-2025-0000036
Event type breakdown
Recalls
74 recall events for this product code
- Merit Medical Systems, Inc.TerminatedJan 30, 2014
Radial Assist RAD BOARD, used to support the
Merit Medical Systems, Inc. is voluntarily recalling one lot (B507171) of RAD BOARD RB 100 devices. The affected devices are missing the main label which graphically depicts patient orientation on the board. The issue may allow the board to be oriented in the wrong direction where the semi-radiopaque material in the board (embedded Xenolite) could obscure patient anatomy during fluoroscopy. There
Z-0901-2014 · View FDA record ↗ - Innovative Orthopedic Technologies, LLCTerminatedUnknown
ARCH Leg Positioning System
Due to the holes not being bored to the specific diameter, the locking pins are unable to engage under a load.
Z-0072-2022 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
7.2cm Adjustable Drill Guide
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1958-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
19CM ATTACHMENT, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1959-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
11.25CM ATTACHMENT, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1960-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
LARGE CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1961-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
STANDARD CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1962-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
GREEN ROTATING CRANIOTOME, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1963-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
ADJUSTABLE DRILL GUIDE, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1964-2017 · View FDA record ↗ - The Anspach Effort, Inc.TerminatedUnknown
16CM MIN INVASIVE ATTACH, BLACK MAX
Supplied Directions for Use (DFU) did not contain a recommended service interval.
Z-1965-2017 · View FDA record ↗
Registered firms
153 firms currently registered for this product code
Shenyang Ourpromise Medical Equipment Co., Ltd.
Shenyang Liaoning, CN
Biocells Discoveries Internacional (biocells)
Quito Pichincha, EC
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Integra Lifesciences Corporation
Princeton, NJ, US
Elucent Medical Inc.
Eden Prairie, MN, US
Medmetalex Co., Ltd.
Osaka, JP
Hefei Mt Medical Co.,ltd.
Hefei Anhui, CN
All Type Welding & Fabrication
Solon, OH, US
Alimed, Llc
DEDHAM, MA, US
Xiamen Liyuan Metal. Co.,ltd.
Xiamen Fujian, CN
Mediview Xr
Cleveland, OH, US
Shanghai No. 2 Medical College Duhang Medical Equipment Factory
Shanghai, CN
Getinge Ab
POZNAN Wielkopolskie, PL
Guilin Yikeshi Medical Device Co Ltd
Guilin Guangxi, CN
Apothecaries Sundries Mfg Pvt Ltd
GURUGRAM Haryana, IN
Innovative Orthopedic Technologies Iot Ag
Buchs Sankt Gallen, CH
Maquet Gmbh
RASTATT Baden-Wurttemberg, DE
Steris Italy S.r.l.
Pomezia Roma, IT
Ortosistemas, S.a.
Panama, PA
Kyra Medical, Inc.
Northborough, MA, US
Depuy Orthopaedics, Inc.
WARSAW, IN, US
Qingdao Zhixing Medical Instrument Co., Ltd.
QingDao Shandong, CN
La Ada De Acuna
CIUDAD DE ACUNA Coahuila, MX
Protection Products, Inc.
Hickory, NC, US
Hi-life Technology (hebei) Co.,ltd.
Bazhou Hebei, CN
510(k) clearances
20 clearances for this product code
- Alpha Surgical, Inc.Jul 13, 1994
K942699 · AIRFRAME SURGICAL DRAPE SUPPORT
- Infinitech, Inc.Feb 7, 1994
K935441 · INFINITECH BREATH EZ
- Instrumentation Specialties, Inc.Apr 29, 1993
K925005 · ISI SELF-SUPPORTING ARM
- Yamashita and Hemsley Business TrustFeb 10, 1993
K922288 · HOLDER, PEDIATRIC POSITION
- Smith & Nephew Equipment GroupApr 2, 1991
K910783 · SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M
- Sds Dental, Inc.Sep 10, 1990
K902865 · BAUMER SURGICAL TABLE
- Mend Technologies, Inc.Nov 17, 1988
K884558 · IOP ADJUSTABLE STIRRUP
- T. Korossurgical Instruments Corp.Jan 22, 1988
K875291 · SPINAL SURGERY FRAME