Hemostat
General, Plastic Surgery · 21 CFR 878.4800
Recent MDR events
93 adverse event reports on file
- CARDINAL HEALTHMar 19, 2026MalfunctionCardinal Health 200, Llc24638524
- OCHSNER FCPS 8 STR SATINJul 14, 2025MalfunctionIntegra Lifesciences Mansfield3014334038-2025-00101
- CRILE FCPS 5-1/2 CVD SATINJul 7, 2025MalfunctionIntegra Lifesciences Mansfield3014334038-2025-00097
- CRILE FCPS 5-1/2 CVD SATINJul 3, 2025MalfunctionIntegra Lifesciences Mansfield3014334038-2025-00094
- KELLY FORCEPS DEL CVD 140MMMar 18, 2025InjuryAesculap Inc.2916714-2025-00010
- INTEGRA® JARIT®Mar 13, 2025MalfunctionIntegra Lifesciences Production Corporation21593359
- KELLY FORCEPS DEL CVD 140MMMar 5, 2025InjuryAesculap Ag9610612-2025-00045
- AESCULAPFeb 18, 2025MalfunctionAesculap Ag21392089
- VANTAGE DOYEN FCPS 9 STRFeb 13, 2025InjuryIntegra Lifesciences Mansfield3014334038-2025-00015
- CARDINAL HEALTHJan 30, 2025MalfunctionCardinal Health 200, Llc21273352
Event type breakdown
Recalls
3 recall events for this product code
- Aesculap IncOpen, ClassifiedMar 11, 2025
Numerous models of nonsterile hemostatic forceps:
The forceps have been used in ways not covered by the design resulting in breakage of the clamps.
Z-1309-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedDec 23, 2024
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
Z-0754-2025 · View FDA record ↗ - MEDLINE INDUSTRIES, LP - NorthfieldOpen, ClassifiedMar 29, 2024
Centurion Hemostat kits labeled as:
Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.
Z-1438-2024 · View FDA record ↗
Registered firms
188 firms currently registered for this product code
Maryam Trading
SIALKOT Punjab, PK
Symmetry Medical Manufacturing Inc
CLAYPOOL, IN, US
Max Hauser Suddeutsche Chirurgiemechanik Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Deroyal Industries, Inc.
POWELL, TN, US
Eltek Instruments (pvt.) Ltd.
Sialkot Punjab, PK
Huaian Wolfram Surgical Instruments
Huaian Jiangsu, CN
Phoenix Instruments, Inc.
Lisle, IL, US
Tri-state De Mexico, S. De R.l. De C.v.
MEXICALI Baja California, MX
Pilotis Tech Llc
Brookhaven, GA, US
Kls Martin Se & Co. Kg
Muhlheim/Donau Baden-Wurttemberg, DE
Silver Plus Corp.
SIALKOT Punjab, PK
Wexler Surgical, Inc.
HOUSTON, TX, US
H&k International Trade Limited (china)
jinhua Zhejiang, CN
Surgipros Llc
Palmetto, FL, US
United Health Products
Mount Laurel, NJ, US
Spartech Instruments & Co.
SIALKOT, PUNJAB, PK
Opinstruments Gmbh
Rosbach vor der Hoehe Hesse, DE
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Finix Industrial Co., Ltd.
Chang Hua City Changhua, TW
American Medicals
Jacksonville, FL, US
Huaian Frimen Co., Ltd
Huaian Jiangsu, CN
Dr. Frigz International (pvt) Ltd.
SIALKOT, Punjab, PK
Vehu Medical Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Deroyal Industries, Inc.
NEW TAZEWELL, TN, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
510(k) clearances
15 clearances for this product code
- Falcon Instruments, Inc.Aug 11, 1992
K920298 · DISPOSABLE HEMOSTATS
- Applied Medical TechnologiesOct 24, 1989
K895683 · BERNARD VESSEL APPROXIMATOR
- Kinetic Medical ProductsJan 27, 1989
K890245 · SURGICAL HEMOSTATS
- Disposable Sterile Surgical Instruments, Inc.Nov 8, 1988
K884196 · SURGICAL INSTRUMENTS (VARIOUS TYPES & SIZES)
- Far East Intl. Trading Corp.Jun 15, 1988
K881937 · SURGICAL INSTRUMENTS
- Medcomp Technologies, Inc.May 23, 1986
K861807 · MEDCARE HEMOSTATS (STRAIGHT, CURVED, MOSQUITO-TIP)
- I M, Inc.Nov 7, 1984
K844152 · HEMSTATS
- Syntex Corp.Oct 24, 1984
K843593 · SURGIPRESS SURGICAL LOOP