FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134401–134424 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 26, 1988
629V SPIROMETER, PULMONARY FUNCTION ANALYZER
K881402 · BZG
American Electromedics Corp.
Anesthesiology · 175d
Cleared Sep 26, 1988
MYOTRAC
K881416 · HCC
Thought Technology , Ltd.
Neurology · 175d
Cleared Sep 26, 1988
FLOWTRON DVT SYSTEM AC500 PUMP, L501 GARMENT
K881632 · JOW
Huntleigh Technology, Inc.
Cardiovascular · 165d
Cleared Sep 26, 1988
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
K881851 · DSB
Micro Medical, Ltd.
Cardiovascular · 147d
Cleared Sep 26, 1988
VIR-A-VAC EMPTY
K882315 · GAZ
Viratec Corp.
General Hospital · 115d
Cleared Sep 26, 1988
SLT CONTACT LASER SYSTEM ENDOPHOTOCOAGULATION
K882441 · HQB
Surgical Laser Technologies, Inc.
Ophthalmic · 104d
Cleared Sep 26, 1988
VASCULAR ACCESS PORT/CATHETER NO.VP-XXX VASPORT
K882969 · DQY
Gish Biomedical, Inc.
Cardiovascular · 73d
Cleared Sep 26, 1988
SCIMED MEMBRANE OXYGENATOR, MODEL 0600-2A
K883053 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 26, 1988
SCIMED ULTROX TRUE MEMBRANE OXY. ULTROX I & II
K883054 · DTZ
Scimed Life Systems, Inc.
Cardiovascular · 69d
Cleared Sep 26, 1988
PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)
K883135 · DWS
Pioneering Technologies, Inc.
Cardiovascular · 62d