FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: General Hospital ×
17,791 results
9409–9432 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Mar 05, 1997
BIOJECTOR 2000 MODEL 1B02000
K960373 · KZE
Bioject, Inc.
General Hospital · 404d
Cleared Mar 05, 1997
V-CATH
K964966 · FOZ
Hdc Corp.
General Hospital · 84d
Cleared Mar 05, 1997
LATEX EXAM GLOVES
K965155 · LYY
P.T. Irama Dinamika Latex
General Hospital · 72d
Cleared Mar 05, 1997
BIOPSY TRAY
K970152 · FRG
Medcare Medical Group, Inc.
General Hospital · 48d
Cleared Mar 04, 1997
EZTEST-GAS
K930683 · FRC
Sgm Biomedical, Inc.
General Hospital · 1483d
Cleared Mar 04, 1997
STRYKER ENCORE STERILIZER
K962755 · FLE
Stryker Corp.
General Hospital · 231d
Cleared Mar 04, 1997
PERIPHERALLY INSERTED MEDLINE CATHETER
K963257 · LJS
Arrow Intl., Inc.
General Hospital · 197d
Cleared Mar 04, 1997
BRANNON ARTERIO-VENOUS PORTSYRINGE
K965030 · FMF
Vascular Logics, Inc.
General Hospital · 77d
Cleared Mar 03, 1997
PROCEDURE SPECIFIC KITS
K964168 · FXX
Sage Products, Inc.
General Hospital · 137d
Cleared Mar 03, 1997
SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT
K964698 · JKA
Andwin Scientific
General Hospital · 101d
Cleared Mar 03, 1997
BIOSEARCH SYRING FLUSHING/CLEANING PUMP FOR BIOSEARCH ENDOSCOPIC INSTRUMENTS
K964871 · FEB
Biosearch Medical Products, Inc.
General Hospital · 88d
Cleared Feb 28, 1997
DELTA
K945117 · FLE
Pelton & Crane Co.
General Hospital · 864d
Cleared Feb 28, 1997
SA.EF(TM) INFUSION PORT II - CONNECTOR AND EXTENSION SET
K964876 · FPA
Vlv Associates, Inc.
General Hospital · 85d
Cleared Feb 27, 1997
BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED...
K962666 · FYA
Bemiss-Jason Corp., Triad Medical Div.
General Hospital · 233d
Cleared Feb 27, 1997
JINHUA LATEX EXAM GLOVE, POWDER FREE WITH PROTEIN LABELING
K964845 · LYY
Jinhua Latex Products Factory
General Hospital · 86d
Cleared Feb 27, 1997
NINGBO YUJIANG LATEX EXAMINATION GLOVES, POWDER-FREE, WITH PROTEIN LABELING
K964847 · LYY
Ningbo Yujiang Plastic & Rubber Co. ,...
General Hospital · 86d
Cleared Feb 27, 1997
MR EXTENSION SET (001)
K964968 · FPA
University of Michigan
General Hospital · 77d
Cleared Feb 26, 1997
MODELS IDA-2 PLUS AND IPT-1
K961862 · FRN
Bio-Tek Instruments, Inc.
General Hospital · 288d
Cleared Feb 26, 1997
LIFESHIELD BLUNT CANNULA
K963351 · FMI
Abbott Laboratories
General Hospital · 184d
Cleared Feb 26, 1997
SPONGETRAC
K964181 · MRL
Surgitrac Corp.
General Hospital · 131d
Cleared Feb 26, 1997
POLYFIN EXTENSION SET, MODELS 126 AND 128
K965208 · FPK
Medtronic Minimed
General Hospital · 61d
Cleared Feb 25, 1997
MASK SURGICAL
K963568 · FXX
The Innovative Approach, Corp.
General Hospital · 173d
Cleared Feb 25, 1997
EZTEST
K963841 · FRC
Sgm Biotech, Inc.
General Hospital · 153d
Cleared Feb 25, 1997
MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS
K964142 · KKX
Medline Industries, Inc.
General Hospital · 132d