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
6481–6504 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Jul 02, 2004
ILLUSION POWDER FREE-POLYMER COATED COLOR SCENTED NR LATEX EXAMINATION GLOVES...
K041004 · LYY
Purna Bina Sdn Bhd
General Hospital · 74d
Cleared Jun 30, 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · FRN
Abbott Laboratories
General Hospital · 21d
Cleared Jun 30, 2004
CONTACT DETACH
K041545 · FPA
Unomedical A/S
General Hospital · 21d
Cleared Jun 30, 2004
MODIFICATION TO: MONOJET PREFILL 0.9% SODIUM CHLORIDE FLUSH SYRINGE, MONOJET...
K032438 · NGT
Tyco Healthcare
General Hospital · 328d
Cleared Jun 25, 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · FRN
Baxter Healthcare Corp
General Hospital · 50d
Cleared Jun 25, 2004
IMALUX OCT PROBE GUIDE
K041077 · KKX
Imalux Corporation
General Hospital · 60d
Cleared Jun 25, 2004
SPSMEDICAL AIRVIEW BOWIE DICK TEST PACK
K041017 · JOJ
Spsmedical Supply Corp.
General Hospital · 66d
Cleared Jun 24, 2004
HUMAN SUBCUTANEOUS INJECTOR, MODEL HSI 500
K041280 · KZE
Felton International, Inc.
General Hospital · 42d
Cleared Jun 24, 2004
POWDER FREE LATEX EXAMINATION GLOVES
K033533 · LYY
Apl International Incorporated Limited
General Hospital · 227d
Cleared Jun 23, 2004
AUTODETECT SYRINGE
K041590 · FMF
Indigo Orb, Inc.
General Hospital · 9d
Cleared Jun 22, 2004
POWDERED LATEX SURGEON'S GLOVES
K031368 · KGO
Cephas Medical Private , Ltd.
General Hospital · 419d
Cleared Jun 21, 2004
PHOENIX PHOTOTHERAPY UNIT CFL, MODEL 101
K040853 · LBI
International Hospital Supply Co.
General Hospital · 81d
Cleared Jun 17, 2004
THERMOMETER MODELS ST313C/F, ST314C/F, ST323C/F, ST324C/F, ST333C/F, ST334C/F
K023956 · FLL
Mesure Technology Co., Ltd.
General Hospital · 568d
Cleared Jun 16, 2004
DISPOSABLE POWDER FREE VINYL EXAMINATION GLOVES
K040967 · LYZ
Zi BO Hong Wang Plastic & Rubber...
General Hospital · 63d
Cleared Jun 10, 2004
INCUBATOR CAPE
K040794 · MMP
Wrapped IN Comfort
General Hospital · 73d
Cleared Jun 08, 2004
NON STERILE SYNTHETIC POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION GLOVES
K041041 · LYZ
Shanghai Foremost Plastic Industrial...
General Hospital · 47d
Cleared Jun 07, 2004
VALUMAX SURGICAL MASKS (BLUE, PINK, GREEN, YELLOW, WHITE AND PEACH) WITH OR...
K040333 · FXX
Valumax Intl., Inc.
General Hospital · 117d
Cleared Jun 04, 2004
MODIFICATION TO THE NAC PLUS NEEDLELESS ACCESS CONNECTOR
K041179 · FPA
Medegen Medical Manufacturing...
General Hospital · 29d
Cleared Jun 03, 2004
POLYMER COAT, POWDER FREE NITRILE EXAMINATION GLOVE (BLUE)
K040791 · LZA
Pt. Smartglove Indonesia
General Hospital · 66d
Cleared Jun 03, 2004
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K040681 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 79d
Cleared Jun 03, 2004
PSI-TEC PERISTALTIC INFILTRATION PUMP
K040149 · FRN
Byron Medical
General Hospital · 132d
Cleared Jun 03, 2004
ENNOBLE DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH VITAMIN...
K040071 · LYZ
Elite International, Inc.
General Hospital · 141d
Cleared Jun 03, 2004
THERMOFOCUS 0800, 0900, 01500 AND 0700 SERIES
K033790 · FLL
Tecnimed S.R.L.
General Hospital · 182d
Cleared Jun 03, 2004
LILY VOLUME METERIC ADMINISTRATION SET, MODELS IB-2111 AND CIB-120ES
K032767 · FPA
Lily Medical Supplies Co., Ltd.
General Hospital · 272d