FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
89401–89424 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1998
SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
K981800 · HIH
Equal Diagnostics, Inc.
Toxicology · 46d
Cleared Jul 06, 1998
CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I RAPID TEST
K981882 · MMI
Princeton BioMeditech Corp.
Chemistry · 39d
Cleared Jul 06, 1998
VIGIL HEMOGLOBIN (HBALC) CONTROLS
K982022 · JJX
Beckman Coulter, Inc.
Hematology · 27d
Cleared Jul 02, 1998
NORTH AMERICAN SCIENTIFIC(NASI)PD-103 RADIONUCLIDE BRACHYTHERAPY SOURCE-MODEL...
K973363 · IWI
Ml Strategies, Inc.
Radiology · 297d
Cleared Jul 02, 1998
SIGMA PLUS MONOPLACE HYPERBARIC CHAMBER
K974868 · CBF
Perry Baromedical Corp.
Anesthesiology · 185d
Cleared Jul 02, 1998
OSTEOGRAF/N-300
K981182 · LYC
Ceramed Dental, LLC
Dental · 92d
Cleared Jul 02, 1998
KYPHON INFLATABLE BONE TAMP
K981251 · HRX
Kyphon, Inc.
Orthopedic · 87d
Cleared Jul 02, 1998
ARISTON PHC
K981264 · EBF
Ivoclar USA, Inc.
Dental · 86d
Cleared Jul 02, 1998
ARISTON PHC LINER
K981335 · EMA
Ivoclar North America, Inc.
Dental · 80d
Cleared Jul 02, 1998
POREX NOSTRIL RETAINERS
K981374 · LYA
Porex Surgical, Inc.
Ear, Nose, Throat · 77d
Cleared Jul 02, 1998
BABY PACIFIER DIGITAL THERMOMETER
K981456 · FLL
K-Jump Health Co., Ltd.
General Hospital · 70d
Cleared Jul 02, 1998
AC/AD LINEARITY VERIFIERS
K982217 · DIF
Sc Calibrators & Controls, LLC
Toxicology · 8d
Cleared Jul 01, 1998
CARDIMA PATHFINDER 1.5F MAPPING MICROCATHETER
K971975 · DRF
Cardima, Inc.
Cardiovascular · 398d
Cleared Jul 01, 1998
HAKIM PROGRAMMABLE VALVE SYSTEM
K974739 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 194d
Cleared Jul 01, 1998
PRESDURE PRODUCTS PRESSURE PADS, MODELS P100, P110, P120, P130, P200, P210,...
K980087 · DXC
Pressure Products, Inc.
Cardiovascular · 173d
Cleared Jul 01, 1998
CRYO-HIT MODEL NUMBERS EP3T3, EP5T2, EP5T5, EP7T5, EP8T5
K980913 · GEI
Galil Medical , Ltd.
General & Plastic Surgery · 113d
Cleared Jul 01, 1998
ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001
K981187 · HWC
Arthrex, Inc.
Orthopedic · 90d
Cleared Jul 01, 1998
UNIVERSAL INSTRUMENT REGISTRATION (UIR) MICROSCOPE MODULE I
K981213 · HAW
Radionics, Inc.
Neurology · 90d
Cleared Jul 01, 1998
PSI-TEC LIPOSUCTION ASPIRATOR
K981215 · QPB
Byron Medical
General & Plastic Surgery · 90d
Cleared Jul 01, 1998
SILCAST (CODE NAME RD-0118)
K981247 · EJS
J.F. Jelenko & Co., Inc.
Dental · 86d
Cleared Jul 01, 1998
STAIR-LIFT
K981486 · ING
Garaventa (Canada) , Ltd.
Physical Medicine · 68d
Cleared Jul 01, 1998
HERNIA MESH STABILIZER
K981598 · GCJ
Medivices Co.
General & Plastic Surgery · 58d
Cleared Jun 30, 1998
SENSE TECHNOLOGY INC. FRAS, SENSE TECHNOLOGY INC. PULSTAR
K973914 · LXM
Sense Technology, Inc.
Physical Medicine · 259d
Cleared Jun 30, 1998
MRI COMPATIBLE MONITOR AND ACCESSORIES
K980362 · DPS
Datex-Engstrom, Inc.
Cardiovascular · 152d