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
123121–123144 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 1991
SURGILASE SL 150 SURGICAL LASER SYSTEM
K905006 · GEX
Surgilase, Inc.
General & Plastic Surgery · 107d
Cleared Feb 21, 1991
SURGICAL MASK
K905209 · FXX
Lancaster County Blind Assoc.
General Hospital · 93d
Cleared Feb 21, 1991
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · HBO
Codman & Shurtleff, Inc.
Neurology · 79d
Cleared Feb 21, 1991
VALLEYLAB E1554 REDUCED ESCHAR ELECTRODE
K905529 · GEI
Valleylab, Inc.
General & Plastic Surgery · 73d
Cleared Feb 21, 1991
PREP AND OPERATING STAND
K905564 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 71d
Cleared Feb 21, 1991
LATERAL BUTTRESS SUPPORT
K905565 · FWZ
Mcconnell Orthopedic
General & Plastic Surgery · 71d
Cleared Feb 21, 1991
VENTREX COATED TUBE IGE RADIOIMMUNOASSAY
K905612 · DGC
Ventrex Laboratories, Inc.
Immunology · 69d
Cleared Feb 21, 1991
CVIS INSIGHT IMAGING CATHETER
K905625 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 69d
Cleared Feb 21, 1991
PHARMACIA DELFIA NEONATAL HTSH KIT
K905710 · JLW
Pharmacia, Inc.
Chemistry · 62d
Cleared Feb 21, 1991
OPUS GENTAMICIN
K905721 · LCQ
Pb Diagnostic Systems, Inc.
Toxicology · 62d
Cleared Feb 21, 1991
TOTAL PROTEIN REAGENT SET
K905790 · CEK
Biochemical Trade, Inc.
Chemistry · 56d
Cleared Feb 21, 1991
EBV IGM ELISA TEST
K910042 · LJN
Gull Laboratories, Inc.
Microbiology · 48d
Cleared Feb 21, 1991
STRYKER LAPAROSCOPE
K910132 · GCJ
Stryker Corp.
General & Plastic Surgery · 43d
Cleared Feb 21, 1991
PLP LAPAROSCOPIC CHOLECYSTECTOMY DIS. ELEC. PROBES
K910184 · GEI
Precision Laser Products, Inc.
General & Plastic Surgery · 37d
Cleared Feb 21, 1991
ELECTROCAUTERY PROBE
K910334 · GEI
Wiltek Medical, Inc.
General & Plastic Surgery · 27d
Cleared Feb 21, 1991
PACIFIC MARQUIS SPA
K910607 · ILJ
Marquis International , Ltd.
Physical Medicine · 9d
Cleared Feb 20, 1991
SCREW-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900179 · DZE
Core-Vent Corp.
Dental · 400d
Cleared Feb 20, 1991
MICRO-VENT ENDOSSEOUS IMPLANT ABUTMENTS
K900181 · DZE
Core-Vent Corp.
Dental · 400d
Cleared Feb 20, 1991
INTHERM TEMPORARY OCCLUSION CATHETER
K901287 · DYG
Interventional Therapeutics Corp.
Cardiovascular · 337d
Cleared Feb 20, 1991
DIA IMPRESSION COPING
K902435 · DZE
Dental Imaging Assoc., Inc.
Dental · 265d
Cleared Feb 20, 1991
NITRATE DISK
K905163 · JTO
Remel Co.
Microbiology · 96d
Cleared Feb 20, 1991
MIDDLE EAR ANALYZER, MODEL AE-803
K905213 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 92d
Cleared Feb 20, 1991
ASEPTIMINI UNIT, ADU-10
K905401 · EIA
Aseptico, Inc.
Dental · 79d
Cleared Feb 20, 1991
STOMADENT TM
K905476 · EBF
Dentsply Intl.
Dental · 76d