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
4945–4968 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 20, 2009
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR)
K092498 · LZA
La Glove (M) Sdn. Bhd.
General Hospital · 98d
Cleared Nov 18, 2009
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840,...
K092040 · LJS
R4 Vascular, Inc.
General Hospital · 139d
Cleared Nov 18, 2009
VPS CATHETER
K091924 · LJS
Vasonova, Inc.
General Hospital · 141d
Cleared Nov 12, 2009
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED...
K093169 · FYA
A Plus International, Inc.
General Hospital · 36d
Cleared Nov 12, 2009
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · LHI
Nipro Medical Corporation
General Hospital · 107d
Cleared Nov 04, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093276 · LYZ
Tangshan Kangyuan Glove Co., Ltd.
General Hospital · 16d
Cleared Nov 04, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K093270 · LYZ
Tangshan Excellence Glove Co., Ltd.
General Hospital · 16d
Cleared Nov 04, 2009
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000
K092490 · FLE
STERIS Corporation
General Hospital · 83d
Cleared Nov 04, 2009
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K092313 · MEA
B.Braun Medical, Inc.
General Hospital · 97d
Cleared Nov 04, 2009
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE
K092072 · LZA
Gx Corporation Sdn Bhd
General Hospital · 119d
Cleared Nov 02, 2009
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES
K092790 · LYZ
Zibo Boxiang Plastic & Rubber Co., Ltd.
General Hospital · 53d
Cleared Nov 02, 2009
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400,...
K092167 · FRG
Kimberly-Clark Corp.
General Hospital · 104d
Cleared Nov 02, 2009
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY...
K091643 · LZC
Gx Corporation Sdn Bhd
General Hospital · 151d
Cleared Oct 30, 2009
ESTEEM SMT POLYISOPRENE POWDER-FREE SURGICAL STERILE GLOVES
K093300 · KGO
Cardinal Health, Inc.
General Hospital · 9d
Cleared Oct 30, 2009
BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE
K092318 · LHI
Baxter Healthcare Corporation
General Hospital · 87d
Cleared Oct 30, 2009
SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2
K091736 · MMK
Daniels Corporation Pty, Inc.
General Hospital · 141d
Cleared Oct 30, 2009
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET
K091441 · FRN
Synergetics, Inc.
General Hospital · 168d
Cleared Oct 27, 2009
ACACIA PISTON SYRINGE
K092986 · FMF
Acacia, Inc.
General Hospital · 29d
Cleared Oct 27, 2009
VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR
K091174 · JOJ
STERIS Corporation
General Hospital · 188d
Cleared Oct 22, 2009
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, (YELLOW, WHITE, BLUE, PINK)
K092301 · LYZ
Bettercare Plastic Products Co., Ltd.
General Hospital · 85d
Cleared Oct 22, 2009
EQUALSHIELD LUER LOCK CONNECTOR PAIR
K091389 · LHI
Plastmed, Ltd.
General Hospital · 164d
Cleared Oct 21, 2009
N95 RESPIRATOR MASK, POSITIVE FACIAL LOCK WITH MAGIC ARCH, MODEL 695
K092824 · MSH
Alpha Protech, Inc.
General Hospital · 37d
Cleared Oct 21, 2009
POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, NON-STERILE, WITH...
K092492 · LYY
Wear Safe Malaysia Sdn. Bhd.
General Hospital · 69d
Cleared Oct 21, 2009
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA (YELLOW,...
K092411 · LZA
Shen Wei (Usa), Inc.
General Hospital · 75d