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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
103777–103800 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 21, 1995
MULTIPLE (IZON URINE COLLECTION KIT)
K950246 · JXA
Izon Business Products, Inc.
Chemistry · 60d
Cleared Mar 21, 1995
VISUALINE II COCAINE
K950369 · DIO
Sun Biomedical Laboratories, Inc.
Toxicology · 49d
Cleared Mar 21, 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · JXM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 47d
Cleared Mar 21, 1995
M-29 PP-PC, M-29 PP-O/PC
K950451 · ESD
Rexton, Inc.
Ear, Nose, Throat · 46d
Cleared Mar 21, 1995
HOWMEDICA V40 22MM FEMORAL HEAD
K950541 · LWJ
Howmedica Corp.
Orthopedic · 42d
Cleared Mar 21, 1995
MAICO IN-THE-EAR MODEL RD-312 CIC
K950637 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 36d
Cleared Mar 21, 1995
DYNA 231X
K950758 · ESD
Phonak, Inc.
Ear, Nose, Throat · 32d
Cleared Mar 21, 1995
HORIZON 55 BI-CON TORIC
K950818 · LPL
Westcon Contact Lens Co., Inc.
Ophthalmic · 26d
Cleared Mar 21, 1995
SCREENING AUDIOMETRY WORD RECOGNITION AUDIOMETRY
K950888 · EWO
Calmed Technology, Inc.
Ear, Nose, Throat · 21d
Cleared Mar 21, 1995
MEGA-SIL A-B
K950912 · ESD
Microsonic, Inc.
Ear, Nose, Throat · 22d
Cleared Mar 21, 1995
HAPEX MALLEABLE TORP
K950927 · ETA
Smith & Nephew Richards, Inc.
Ear, Nose, Throat · 20d
Cleared Mar 21, 1995
KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS
K950976 · FBK
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 20d
Cleared Mar 20, 1995
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
K941990 · LFI
Bio-Rad
Toxicology · 329d
Cleared Mar 20, 1995
BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC
K941994 · LFI
Bio-Rad
Toxicology · 329d
Cleared Mar 20, 1995
OXYCON-ALPHA
K942230 · BTY
Mijnhardt B.V.
Anesthesiology · 318d
Cleared Mar 20, 1995
CARBON DIOXIDE (C02)
K942735 · KHS
Teco Diagnostics
Chemistry · 283d
Cleared Mar 20, 1995
BIOABSORBABLE INTERFERENCE SCREW
K943548 · JDR
Acufex Microsurgical, Inc.
Orthopedic · 242d
Cleared Mar 20, 1995
125MM HANDPIECE
K945228 · GEX
Plc Medical Systems, Inc.
General & Plastic Surgery · 145d
Cleared Mar 20, 1995
AURAFLEX HCG
K945331 · DHA
Organon Teknika Corp.
Chemistry · 139d
Cleared Mar 20, 1995
MCINTOSH, MILLER, FOREGGER BABY
K945425 · CCW
Rudolf Riester GmbH & Co. KG
Anesthesiology · 136d
Cleared Mar 20, 1995
SURGICLA INSTRUMENT KIT
K946019 · FRG
Medical Action Industries, Inc.
General Hospital · 98d
Cleared Mar 20, 1995
HOWMEDICA(R) 28MM ZIRCONIA FEMORAL HEADS
K946026 · LZO
Howmedica, Inc.
Orthopedic · 98d
Cleared Mar 20, 1995
URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE
K950183 · LCM
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 62d
Cleared Mar 20, 1995
KENLOR HUMAN SPINAL FLUID CONTROL
K950326 · JJY
Kenlor Industries, Inc.
Chemistry · 61d