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
8689–8712 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Nov 30, 1998
UNISEAL GLOVES LOW PROTEIN POWDERED
K981979 · LYY
American Healthcare Products (M) Sdn Bhd
General Hospital · 178d
Cleared Nov 30, 1998
ROTECNO 2000 SURGICAL GOWN
K982059 · FYA
Encompass Group, LLC
General Hospital · 172d
Cleared Nov 30, 1998
FLUIDSENSE FLUID DELIVERY SYSTEM
K982170 · FRN
Fluidsense Corp.
General Hospital · 164d
Cleared Nov 30, 1998
NITRILE POWDER-FREE UNISEAL GLOVES
K982218 · LZA
American Healthcare Products (M) Sdn Bhd
General Hospital · 159d
Cleared Nov 30, 1998
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · LYY
Ansell Perry
General Hospital · 138d
Cleared Nov 30, 1998
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE, WITH PROTEIN CLAIM
K982716 · LYY
Omnigrace (Thailand) , Ltd.
General Hospital · 118d
Cleared Nov 30, 1998
MATANG POWDER-FREE LOW PROTEIN LATEX PATIENT EXAMINATION GLOVE
K982877 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 108d
Cleared Nov 30, 1998
NEUTRALON PF POWDER FREE BROWN LATEX SURGICAL GLOVES
K983240 · KGO
Johnson & Johnson Medical, Div. of...
General Hospital · 76d
Cleared Nov 30, 1998
POWDERED NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983531 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 53d
Cleared Nov 30, 1998
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED
K983532 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 53d
Cleared Nov 30, 1998
DEROYAL INDUSTRIES, INC TRACECART SHARPS COLLECTION CONTAINER
K983750 · FMI
Deroyal Industries, Inc.
General Hospital · 38d
Cleared Nov 30, 1998
DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH
K983869 · LRJ
Caltech Industries, Inc.
General Hospital · 28d
Cleared Nov 30, 1998
BELMONT FLUID MANAGEMENT SYSTEM (FMS2000)
K983975 · FRN
Belmont Instrument Corp.
General Hospital · 21d
Cleared Nov 24, 1998
SHUN-THAI - SAFE-CONTACT, BOSTON MEDICAL LATEX EXAM GLOVE, SHUN-THAI LATEX...
K982416 · LYY
Shun Thai Rubber Gloves Industry Co.,...
General Hospital · 134d
Cleared Nov 23, 1998
BPOS-IVAD STABILIZER
K983480 · LJT
Bpos, Inc.
General Hospital · 52d
Cleared Nov 23, 1998
V-CATH PICC (PERIPHERALLY INSERTED CENTRAL CATHETER)
K983916 · FOZ
Hdc Corp.
General Hospital · 20d
Cleared Nov 20, 1998
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 168d
Cleared Nov 20, 1998
STERI-PAK BOWIE DICK TEST PACK
K982188 · JOJ
Steritec Products Mfg Co, Inc.
General Hospital · 151d
Cleared Nov 20, 1998
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · FRN
Abbott Laboratories
General Hospital · 30d
Cleared Nov 18, 1998
NMT SAFETY SYRINGE
K982431 · MEG
New Medical Technology , Ltd.
General Hospital · 128d
Cleared Nov 18, 1998
PAINBUSTER INFUSION KIT
K982946 · MEB
I-Flow Corp.
General Hospital · 89d
Cleared Nov 17, 1998
BONE INJECTION GUN (B.I.G.) DEVICE
K981853 · FMI
Waismed, Ltd.
General Hospital · 175d
Cleared Nov 13, 1998
BLOWER/MISTER
K983135 · FQH
Cardiothoracic Systems, Inc.
General Hospital · 66d
Cleared Nov 06, 1998
PROPPER EO LINE ETHYLENE OXIDE STERILIZATION INTEGRATOR
K973585 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 410d