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
7081–7104 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Sep 25, 2002
ILLUSION POWDER FREE-PLOYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES...
K022659 · LYY
Purna Bina Sdn Bhd
General Hospital · 47d
Cleared Sep 25, 2002
BARDPORT X-PORT ISP PORT
K022983 · LJT
C.R. Bard, Inc.
General Hospital · 16d
Cleared Sep 23, 2002
PRIMAGARD NONSTERILE FEMORAL ANGIOGRAPHY DRAPES (MODELS PM1-0136, PM1-0119,...
K021864 · KKX
Primeline Medical Products, Inc.
General Hospital · 109d
Cleared Sep 23, 2002
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIMS, GREEN COLOR
K022220 · LYY
Shen Wei (Usa), Inc.
General Hospital · 76d
Cleared Sep 20, 2002
SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S,...
K022099 · FOZ
Hdc Corp.
General Hospital · 85d
Cleared Sep 20, 2002
SOAKER CATHETER
K022869 · FRN
I-Flow Corp.
General Hospital · 22d
Cleared Sep 19, 2002
NATUS BLUE LIGHT PHOTOTHERAPY UNIT
K022196 · LBI
Natus Medical, Inc.
General Hospital · 76d
Cleared Sep 19, 2002
CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC...
K022387 · LLI
Craftmatic Organization, Inc.
General Hospital · 58d
Cleared Sep 19, 2002
DUOPRO SAFETY SYRINGE (DUOPROSS)
K022806 · MEG
M.K. Meditech Co. , Ltd.
General Hospital · 27d
Cleared Sep 18, 2002
STERILOX LIQUID CHEMICAL STERILANT SYSTEM
K013280 · MED
Sterilox Technologies, Inc.
General Hospital · 351d
Cleared Sep 18, 2002
COLOSHIELD COLONOSCOPY DRAPE MODEL E2000
K020581 · KKX
Medical Concepts Development, Inc.
General Hospital · 209d
Cleared Sep 17, 2002
POWDER FREE GREEN NEOPRENE SURGICAL GLOVES, STERILE WITH ALOE VERA
K022444 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 54d
Cleared Sep 17, 2002
POWDER-FREE, LATEX EXAMINATION GLOVE COATED WITH ALOE VERA GEL AND VITAMIN E
K022701 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 34d
Cleared Sep 17, 2002
MULTIPLE, BLUE POWDER FREE NITRILE EXAMINATION GLOVES WITH PEPPERMINT FLAVOR
K022818 · LZA
Smart Glove Corp. Sdn Bhd
General Hospital · 22d
Cleared Sep 17, 2002
BRIGHTWAY BRAND COLORED POWDER FREE NITRILE EXAMINATION GLOVES (ORANGE)
K022878 · LZA
Brightway Holdings Sdn. Bhd.
General Hospital · 18d
Cleared Sep 16, 2002
ULTI GUARD HOME INSULIN SYRINGE CONTAINER
K021983 · MMK
Ultimed, Inc.
General Hospital · 90d
Cleared Sep 16, 2002
GLOVETEX POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE (PROTEIN CONTENT...
K022343 · LYY
Pt. Wrp Buana Multicorpora
General Hospital · 59d
Cleared Sep 16, 2002
POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES
K022600 · LYZ
Shijiazhuang Wally Plastics Co., Ltd.
General Hospital · 42d
Cleared Sep 16, 2002
SYNTHETIC POWDER FREE VINYL PATIENT EXAM GLOVES
K022639 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 39d
Cleared Sep 16, 2002
POWDERED SYNTHETIC VINYL EXAM GLOVES
K022702 · LYZ
Shijiazhuang Holy Plastics Co., Ltd.
General Hospital · 33d
Cleared Sep 12, 2002
KAWASUMI LABORATORIES ANTINEEDLE STICK PROTECTOR FOR USE WITH PORT ACCESS...
K022110 · LJT
Kawasumi Laboratories, Inc.
General Hospital · 76d
Cleared Sep 12, 2002
TMD SAFETY SYRINGE (FA12 SERIES 3ML/FA13 SERIES 5ML)
K022278 · MEG
Taiject Medical Device Co., Ltd.
General Hospital · 59d
Cleared Sep 11, 2002
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
K022831 · LZG
Disetronic Medical Systems AG
General Hospital · 16d
Cleared Sep 11, 2002
MODIFICATION TO INFANT LIFE SUPPORT MODULE-20
K022876 · FPL
International Biomedical, Inc.
General Hospital · 12d