FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133801–133824 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 28, 1988
STERILIZATION WRAP TYPE 22,44,77
K883376 · FRG
East Texas Lighthouse For the Blind
General Hospital · 50d
Cleared Sep 28, 1988
LINDSTROM CORDLESS EPILATOR
K883429 · KCW
A Place of Health & Beauty
General & Plastic Surgery · 44d
Cleared Sep 28, 1988
HERPES VIRUS CONTROL SLIDES
K883684 · GQN
Val Tech Diagnostics, Inc.
Microbiology · 30d
Cleared Sep 28, 1988
IMMUNO/FEBRILE ANTIGENS
K883685 · GNC
Immunostics Co., Inc.
Microbiology · 30d
Cleared Sep 28, 1988
MANAN HUBER STYLE INFUSION NEEDLE
K883744 · FMF
Manan Medical Products, Inc.
General Hospital · 27d
Cleared Sep 28, 1988
STORZ MODEL 62 ENT CAMERA SYSTEM
K883760 · FWL
Storz Instrument Co.
General & Plastic Surgery · 22d
Cleared Sep 28, 1988
CCM-1 VIDEO CAMERA SYSTEM
K883943 · FTS
Medical Concepts, Inc.
General & Plastic Surgery · 9d
Cleared Sep 28, 1988
MEC-1 VIDEO COMBO SYSTEM
K883944 · FTS
Medical Concepts, Inc.
General & Plastic Surgery · 9d
Cleared Sep 28, 1988
U. V. SUNLAMP 95UF-11
K883952 · FTC
Light Sources, Inc.
General & Plastic Surgery · 9d
Cleared Sep 27, 1988
ACS CORONARY ANGIOSCOPIC CATHETER
K875108 · LYK
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 288d
Cleared Sep 27, 1988
MODEL PM-20A PHYSIOLOGICAL MONITOR
K880756 · DQA
Advanced Medical Systems, Inc.
Anesthesiology · 215d
Cleared Sep 27, 1988
LASER FLARE CELL METER FC-1000
K880920 · HJO
Kowa Optimed, Inc.
Ophthalmic · 207d
Cleared Sep 27, 1988
130 CRYO UNIT & ASSOC. CRYOPROBES & SPRAY
K882568 · GEH
Spembly Medical , Ltd.
General & Plastic Surgery · 97d
Cleared Sep 27, 1988
EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER
K882771 · DWF
Cook, Inc.
Cardiovascular · 83d
Cleared Sep 27, 1988
THYMAPAD
K882809 · GXY
Somatics, Inc.
Neurology · 82d
Cleared Sep 27, 1988
MEMBRANE OXYGENATOR
K882892 · DTZ
Baxter Bentley Laboratories, Inc.
Cardiovascular · 78d
Cleared Sep 27, 1988
TAD INTERMEDIATE & TAD STANDARD GUIDE WIRE
K882928 · DQX
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 81d
Cleared Sep 27, 1988
PTI INTRA-ART CORONARY ARTERY RETRACTION CLIP
K882981 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 74d
Cleared Sep 27, 1988
MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE
K883320 · JKA
Sherwood Medical Co.
Chemistry · 53d
Cleared Sep 27, 1988
HOLOGIC MODEL WHF-1 ANTHROPOMORPHIC FEMUR PHANTOM
K883360 · KGI
Hologic, Inc.
Radiology · 49d
Cleared Sep 27, 1988
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325
K883551 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 39d
Cleared Sep 27, 1988
SHARPLAN 2100 ND:YAG LASER, SERIES 2900 SYN. TIPS
K883563 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 39d
Cleared Sep 27, 1988
BARD EMS SYSTEMS 3400 & 4400 & DUAL PAD ELECTRODE
K883762 · GEI
Bard Electro Medical Systems, Inc.
General & Plastic Surgery · 21d
Cleared Sep 26, 1988
WCCS 800 WALLACH CARDIAC CRYOSURGICAL SYSTEM
K880416 · GEH
Wallach Surgical Devices, Inc.
General & Plastic Surgery · 238d