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
132865–132888 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 14, 1989
MODIFIED LABELING & PACKAGING OF SHARPLAN 2100
K890040 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 40d
Cleared Feb 14, 1989
FACELOCK FILTER MASK
K890128 · FXX
Alpha Protech, Inc.
General Hospital · 33d
Cleared Feb 14, 1989
MALIS SURGICAL STOOL
K890309 · FZM
Valley Forge Scientific Corp.
General & Plastic Surgery · 22d
Cleared Feb 14, 1989
MULTIWELL CULTURE PLATE INSERTS
K890542 · KIZ
Bd Becton Dickinson Vacutainer...
Pathology · 11d
Cleared Feb 13, 1989
POTASSIUM NITRATE POLYCARBOXYLATE DENTAL CEMENT
K882417 · EMA
Milton Hodosh, M.D.
Dental · 245d
Cleared Feb 13, 1989
MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
K883189 · FFK
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 200d
Cleared Feb 13, 1989
AUDIOSCAN(TM) REAL EAR MEASUREMENT SYSTEM RM500
K884046 · ETW
Etymonic Design, Inc.
Ear, Nose, Throat · 140d
Cleared Feb 13, 1989
MADSEN IGO-HAT1500 HEARING AID DISPENSER SYSTEM
K884371 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
MADSEN IGO1500 INSERTION GAIN OPTIMIZER
K884372 · ETW
Madsen Electronics (Canada) , Ltd.
Ear, Nose, Throat · 118d
Cleared Feb 13, 1989
ULTRASONIC TRANSMISSION GEL
K884503 · JOT
Herbert Stanley Co.
General & Plastic Surgery · 111d
Cleared Feb 13, 1989
ULTRA 2000 (T.E.N.S.)
K884833 · GZJ
Maxima Intl., Inc.
Neurology · 87d
Cleared Feb 13, 1989
PORCELAIN ETCHING GEL AND ETCHING GEL BARRIER
K884918 · KLE
Parkell
Dental · 77d
Cleared Feb 13, 1989
ADDIT. INDICATION FOR FYODOROV COLLAGEN CORNEAL
K884960 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 87d
Cleared Feb 13, 1989
ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL
K884961 · MOE
Bausch & Lomb Pharmaceutical, Inc.
Ophthalmic · 87d
Cleared Feb 13, 1989
TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDING
K885010 · KLE
Coe Laboratories, Inc.
Dental · 73d
Cleared Feb 13, 1989
ABIOMED PERIOTEMP(TM) PROBE
K885075 · EIL
Abiomed, Inc.
Dental · 67d
Cleared Feb 13, 1989
NOVA DIAMOND
K885233 · DZP
Microcopy, Div. Neo-Flo, Inc.
Dental · 55d
Cleared Feb 13, 1989
ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS
K885250 · HRS
Howmedica Corp.
Orthopedic · 53d
Cleared Feb 13, 1989
GOLD/PALLADIUM BASED DENTAL ALLOY
K885302 · EJT
Jelenko Co.
Dental · 48d
Cleared Feb 13, 1989
SIT-N-BATHE SITZ BATH
K890085 · KTC
Drummond Industries, Inc.
Physical Medicine · 34d
Cleared Feb 13, 1989
IMPACTOR FOR FEMORAL HEAD
K890156 · LXH
Dhason Brothers, Inc.
Orthopedic · 35d
Cleared Feb 13, 1989
FORCEPS
K890157 · LXH
Dhason Brothers, Inc.
Orthopedic · 35d
Cleared Feb 13, 1989
RETRACTORS
K890158 · LXH
Dhason Brothers, Inc.
Orthopedic · 35d
Cleared Feb 13, 1989
GOUGES FOR FEMORAL HEADS
K890160 · LXH
Dhason Brothers, Inc.
Orthopedic · 35d