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
85609–85632 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 02, 1999
FIXION INTRAMEDULLARY NAILING SYSTEM
K990717 · HSB
Disco-O-Tech Medical Technologies, Ltd.
Orthopedic · 90d
Cleared Jun 02, 1999
OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR
K990922 · KWP
Howmedica Osteonics Corp.
Orthopedic · 75d
Cleared Jun 02, 1999
GENERAL PURPOSE NEOFLEX TRANSDUCER COVER, EDOCAVITY NEOFLEX TRANSDUCER COVER,...
K991236 · ITX
CIVCO Medical Instruments Co., Inc.
Radiology · 51d
Cleared Jun 02, 1999
TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005
K991311 · CDP
Biocheck, Inc.
Chemistry · 47d
Cleared Jun 02, 1999
BIOCHECK TOTAL T4 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1007
K991432 · KLI
Biocheck, Inc.
Chemistry · 37d
Cleared Jun 02, 1999
SYNTHES PEDIATRIC ROD SYSTEM
K991552 · MNH
Synthes (Usa)
Orthopedic · 30d
Cleared Jun 01, 1999
AVOGEL
K981353 · MDA
Avocet Polymer Technologies, Inc.
General & Plastic Surgery · 413d
Cleared Jun 01, 1999
MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000
K982889 · BYI
Electromed, Inc.
Anesthesiology · 288d
Cleared Jun 01, 1999
IMPLEX RADIAL HEAD REPLACEMENT SYSTEM
K984290 · KWI
Implex Corp.
Orthopedic · 182d
Cleared Jun 01, 1999
VITAL PEP
K984468 · BWF
Vital Signs, Inc.
Anesthesiology · 167d
Cleared Jun 01, 1999
KARL STORZ DIRECT COUPLED INTERFACE (DCI 5) CAMERA SYSTEM
K990154 · FWF
Karl Storz Imaging, Inc.
General & Plastic Surgery · 133d
Cleared Jun 01, 1999
ALPHAMED GEMINI SENSOR, SNORING SENSOR
K990321 · MNR
Alphamed, Inc.
Anesthesiology · 120d
Cleared Jun 01, 1999
BONE SCREWS
K990351 · HWC
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
STAINLESS STEEL FIXATION PINS
K990353 · JDW
Bregma International Trading Company...
Orthopedic · 116d
Cleared Jun 01, 1999
COOPERSURGICAL COAGULATOR FOR TATTOO REMOVAL
K990850 · KNS
CooperSurgical, Inc.
Gastroenterology & Urology · 78d
Cleared Jun 01, 1999
VITROS IMMUNODIAGNOSTIC PRODUCTS CEA CALIBRATORS, VITROS IMMUNODIAGNOSTIC...
K990943 · DHX
Ortho-Clinical Diagnostics, Inc.
Immunology · 71d
Cleared Jun 01, 1999
KSEA EPIDUROSCOPE
K991051 · HRX
KARL STORZ Endoscopy-America, Inc.
Orthopedic · 63d
Cleared Jun 01, 1999
COAG-A-MATE MAX
K991101 · GKP
Organon Teknika Corp.
Hematology · 61d
Cleared Jun 01, 1999
PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM
K991123 · LPH
Wrightmedicaltechnologyinc
Orthopedic · 60d
Cleared Jun 01, 1999
MODIFICATION OF N PROTEIN STANDARD SL
K991181 · JIX
Dade Behring, Inc.
Chemistry · 55d
Cleared Jun 01, 1999
FOUNDATION POROUS HIP STEM
K991226 · LZO
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 01, 1999
8MM FORGED CEMENTED STEM
K991227 · JDI
Encore Orthopedics, Inc.
Orthopedic · 50d
Cleared Jun 01, 1999
SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS
K991302 · IXC
Smartlight, Inc.
Radiology · 46d
Cleared Jun 01, 1999
CRP
K991372 · DCN
Abbott Laboratories
Immunology · 42d