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
8041–8064 of 17,791
Search insights Median review: 89d Cleared: 100% Top manufacturer: Baxter Healthcare Corp Lead specialty: General Hospital
Cleared Apr 21, 2000
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · FYA
Allegiance Healthcare Corp.
General Hospital · 9d
Cleared Apr 21, 2000
BIOSHIELD HEAVY DUTY AND SUPER DUTY EXPRESS STERILIZATION WRAP
K993871 · FRG
Allegiance Healthcare Corp.
General Hospital · 158d
Cleared Apr 20, 2000
BETEL POWDER FREE LATEX EXAM GLOVES
K000650 · LYY
Betel Care Sdn. Bhd.
General Hospital · 52d
Cleared Apr 20, 2000
NON-STERILE POWDER-FREE, BLUE NITRILE EXAMINATION GLOVES
K000868 · LZA
Sgmp Co., Ltd.
General Hospital · 34d
Cleared Apr 20, 2000
DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES, WHITE COLOR
K000953 · LYZ
Shanghai Antares Industries, Inc.
General Hospital · 27d
Cleared Apr 20, 2000
PARSET PRIMARY SET WITH CHECK VALVE, MODEL A10002E
K001102 · FPA
Rd Medical Mfg., Inc.
General Hospital · 15d
Cleared Apr 20, 2000
STERILE WATER & STERILE 0.9% SODIUM CHLORIDE
K992732 · FOZ
Dumex Medical Surgical Products, Ltd.
General Hospital · 251d
Cleared Apr 19, 2000
GETTIG GUARD
K000455 · FMI
Gettig Pharmaceutical Instrument Co.
General Hospital · 68d
Cleared Apr 14, 2000
NITRILE PATIENT EXAMINATION GLOVES, POWDER-FREE
K000223 · LZA
Phoenix Medical Technology, Inc.
General Hospital · 81d
Cleared Apr 14, 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · KGO
Wrp Asia Pacific Sdn. Bhd.
General Hospital · 18d
Cleared Apr 12, 2000
JET PORT PLUS CATHETER SYSTEM
K000125 · LJT
Clinical Plastic Products SA
General Hospital · 85d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000390 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
VITAL SHIELD GOLD POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT...
K000391 · LYY
Sgmp Co., Ltd.
General Hospital · 65d
Cleared Apr 12, 2000
TEKMEDIC POWDERED SINGLE-USE LATEX PATIENT EXAMINATION GLOVES WITH PROTEIN &...
K000555 · LYY
Tekmedic (M) Sdn Bhd
General Hospital · 54d
Cleared Apr 12, 2000
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50...
K000584 · LYY
Shasta Asia Partners Gloves...
General Hospital · 50d
Cleared Apr 12, 2000
NITRILE EXAM GLOVE, POWDER FREE, BLUE
K000670 · LZA
Shasta Asia Partners Gloves...
General Hospital · 44d
Cleared Apr 12, 2000
UNIGLOVE NITRILE POWDERED EXAMINATION GLOVES
K000688 · LZA
N.S. Uni-Gloves Sdn. Bhd.
General Hospital · 43d
Cleared Apr 12, 2000
ASAHI STERILE ACUPUNCTURE NEEDLE TYPE S
K000740 · MQX
Asahi Iryoki Co., Ltd.
General Hospital · 36d
Cleared Apr 12, 2000
TEMPTELLER INFRARED EAR THERMOMETER, MODELS TT-901, TT-911 AND TT-921
K001008 · FLL
Oriental System Technology, Inc.
General Hospital · 14d
Cleared Apr 12, 2000
REGENT SKINDENDE EXAM GLOVE, REGENT BIOGEL D, REGENTBIOGEL DIAGNOSTIC...
K991677 · LYY
London International Group, Inc.
General Hospital · 331d
Cleared Apr 12, 2000
IQ CHAMBERS
K992553 · KXF
Dormer Laboratories, Inc.
General Hospital · 257d
Cleared Apr 12, 2000
A&D MEDICAL UT-101 LIFESOURCE DIGITAL EAR THEROMETER
K993116 · FLL
A&D Engineering, Inc.
General Hospital · 205d
Cleared Apr 12, 2000
VINYL PATIENT EXAMINATION GLOVES-PRE-POWDERED
K994099 · LYZ
Evergreen Medical Produts (Jingxing)...
General Hospital · 131d
Cleared Apr 11, 2000
BODYGUARD
K000441 · FMI
Vital Signs, Inc.
General Hospital · 61d