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
121873–121896 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 15, 1991
MICROTEK-HERITAGES SILICONE BULB EVACUATION SYSTEM
K910167 · GCY
Microbio-Medics, Inc.
General & Plastic Surgery · 90d
Cleared Apr 15, 1991
TRANSDUCERS, EUP-C318/V33/F334/CC331/B31/032T
K910268 · ITX
Hitachi Medical Corp.
Radiology · 90d
Cleared Apr 15, 1991
AHL, ITE MODEL AMERICAN
K910325 · ESD
Bob Bare Hearing Aid Repair
Ear, Nose, Throat · 81d
Cleared Apr 15, 1991
HEMOCARD-AS
K910430 · GHM
Isolab, Inc.
Hematology · 73d
Cleared Apr 15, 1991
TYCERAMIC
K910569 · ELL
Jeneric/Pentron, Inc.
Dental · 63d
Cleared Apr 15, 1991
PHONAK 9300 SC-AF ITE HEARING INSTRUMENT
K911209 · ESD
Phonak, Inc.
Ear, Nose, Throat · 27d
Cleared Apr 15, 1991
LIFEPORT VASCU ACCESS SYST/PORT INTRO KIT 7015
K911355 · LJT
Strato Medical Corp.
General Hospital · 53d
Cleared Apr 12, 1991
UTAK LABORATORIES TOXICOLOGY CONTROL
K903061 · LAS
Utak Laboratories, Inc.
Toxicology · 277d
Cleared Apr 12, 1991
CVIS INSIGHT IMAGING CATHETER
K904618 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 183d
Cleared Apr 12, 1991
BC 1206 IMPLANT - INSERT TYPE
K904705 · DZE
Minimatic Implant Technology
Dental · 178d
Cleared Apr 12, 1991
CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS
K904752 · JIR
Boehringer Mannheim Corp.
Chemistry · 175d
Cleared Apr 12, 1991
ADVANCE 418(TM)
K904984 · LIT
Peripheral Systems Group
Cardiovascular · 161d
Cleared Apr 12, 1991
ELECTRODE EXTENDER
K905060 · JOS
Megadyne Medical Products, Inc.
General & Plastic Surgery · 155d
Cleared Apr 12, 1991
DEFIBRILLATOR LEAD ADAPTER
K905065 · LDD
Spacelabs, Inc.
Cardiovascular · 156d
Cleared Apr 12, 1991
INCARE PINSITE DRESSING
K905206 · KOZ
Hollister, Inc.
General & Plastic Surgery · 143d
Cleared Apr 12, 1991
MINIATURE ELECTRODERMAL RESPONSE TRAINER EDR-002
K905372 · HCC
Bio-Feedback Systems, Inc.
Neurology · 134d
Cleared Apr 12, 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 133d
Cleared Apr 12, 1991
ILC FORCEPS PADS
K905583 · HDA
Inman Liebelt Corp.
Obstetrics & Gynecology · 121d
Cleared Apr 12, 1991
BED RED D-DIMER WHOLE BLOOD AGGLUTINATION ASSAY
K905643 · GHH
Agen Biomedical , Ltd.
Hematology · 116d
Cleared Apr 12, 1991
H-TRON V 100 INSULIN INFUSION PUMP
K905693 · LZG
Disetronic Medical Systems
General Hospital · 114d
Cleared Apr 12, 1991
ANTI-FOG DISPOSABLE IV INDUCTION COVER
K910104 · EYF
Central Plastic, Inc.
General & Plastic Surgery · 99d
Cleared Apr 12, 1991
LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST
K910233 · GEX
Laser Photonics, Inc.
General & Plastic Surgery · 84d
Cleared Apr 12, 1991
DANAM DATACELL-18
K910283 · GKZ
Danam Electronics
Hematology · 79d
Cleared Apr 12, 1991
CARDIOLAB AMPLIFIER MODULE (CAM)
K910307 · DRR
Prucka Engineering, Inc.
Cardiovascular · 78d