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
88897–88920 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 30, 1998
AMIGO RT
K981121 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 95d
Cleared Jun 30, 1998
LIPOPLASTY/ LIPOSUCTION ASPIRATION AND TUMESCENT INFUSION CANNULAE AND NEEDLES
K981172 · QPB
Byron Medical
General & Plastic Surgery · 90d
Cleared Jun 30, 1998
HIGH IMPEDANCE CARDIAC GATING CABLE
K981190 · LNH
GE Medical Systems
Radiology · 89d
Cleared Jun 30, 1998
FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT
K981194 · KWH
Nexa Orthopedics, Inc.
Orthopedic · 89d
Cleared Jun 30, 1998
SYMPHONY 360 REMOTE CONTROL TABLE
K981227 · JAA
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 30, 1998
7200 ULTRASOUND IMAGING SYSTEM
K981293 · IYO
Biosound Esaote, Inc.
Radiology · 82d
Cleared Jun 30, 1998
HAMMERSMITH ENDOCAVITARY COILS
K981410 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 71d
Cleared Jun 30, 1998
TIMX LOW BACK SYSTEM TITANIUM MX ROD BASED LOW BACK SYSTEM
K981714 · MNH
Acromed Corp.
Orthopedic · 46d
Cleared Jun 30, 1998
STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
K981717 · FTD
Stryker Instruments
General & Plastic Surgery · 46d