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
133825–133848 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 26, 1988
VITAL-VUE ILLUMINATION, SUCTION & IRRIGATION SYS
K883201 · HBI
Vital Metrics, Inc.
General & Plastic Surgery · 60d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · DTR
Shiley, Inc.
Cardiovascular · 49d
Cleared Sep 26, 1988
SIMPSON PERIPHERAL ATHEROCATH W/ADDIT. SIZE 13F
K883346 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 60d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323
K883548 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STREPTOCOCCUS MIC PANEL #80322
K883549 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR STAPHYLOCOCCUS MIC #80324
K883550 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328
K883552 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331
K883553 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329
K883554 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332
K883555 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 38d
Cleared Sep 26, 1988
FEF(TM) END-TIDAL CO2 DETECTOR
K883821 · CCK
Fenem, Inc.
Anesthesiology · 18d
Cleared Sep 23, 1988
FLOWTRON AC200/2
K874688 · IRP
Huntleigh Technology, Inc.
Physical Medicine · 315d