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
132265–132288 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1989
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K890146 · GRM
Wellcome Diagnostics
Microbiology · 34d
Cleared Feb 16, 1989
MICROSURGICAL KERATOME
K890216 · GZX
Kinetic Medical Products
Neurology · 29d
Cleared Feb 16, 1989
HYSTERECTOMY FORCEPS
K890383 · HCZ
Kinetic Medical Products
Obstetrics & Gynecology · 24d
Cleared Feb 16, 1989
KODAK PORTABLE IDENTIFICATION CAMERA
K890467 · JAC
Eastman Kodak Company
Radiology · 16d
Cleared Feb 15, 1989
CTS-3060 AUTOMATED SEMEN ANALYZER
K881765 · POV
Motion Analysis Corp.
Hematology · 296d
Cleared Feb 15, 1989
XOMED IONESTHETIZER(TM)
K884834 · EGJ
Xomed, Inc.
Physical Medicine · 89d
Cleared Feb 15, 1989
ENDOSTROBOSCOPE IV
K884933 · EQL
Jedmed Instrument Co.
Ear, Nose, Throat · 79d
Cleared Feb 15, 1989
SPQ(TM) ANTIBODY REAGENT SET II FOR IGA
K890560 · CZP
Atlantic Antibodies
Immunology · 22d
Cleared Feb 14, 1989
HOMER MAMMALOK LOCALIZATION SHIELD
K885090 · LRO
North American Instrument Corp.
General & Plastic Surgery · 64d
Cleared Feb 14, 1989
AIR DISPLACEMENT PIPETTE
K885340 · JQW
Ulster Scientific, Inc.
Chemistry · 48d
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