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
88513–88536 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 05, 1998
OTI MODULAR SHOULDER SYSTEM
K982886 · HSD
Osteoimplant Technology, Inc.
Orthopedic · 49d
Cleared Oct 05, 1998
MVM 7.5 FRENCH FLEXIBLE URETEROSCOPE
K982905 · FGB
Karl Storz Endoscopy
Gastroenterology & Urology · 48d
Cleared Oct 05, 1998
DEPUY C-STEM SYSTEM
K982918 · JDI
DePuy Orthopaedics, Inc.
Orthopedic · 47d
Cleared Oct 05, 1998
QUICKIE SUSPENSION WHEELCHAIR SERIES MODEL XTR
K982989 · IOR
Sunrise Medical, Inc.
Physical Medicine · 40d
Cleared Oct 05, 1998
NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160,...
K983121 · HTY
Syntec Scientific Corp.
Orthopedic · 27d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION
K980484 · MNI
Aesculap, Inc.
Orthopedic · 235d
Cleared Oct 02, 1998
HISTOFREEZER DEVICE
K982358 · GEH
OraSure Technologies, Inc.
General & Plastic Surgery · 88d
Cleared Oct 02, 1998
NC-STAT
K982359 · JXE
Neurometrix, Inc.
Neurology · 88d
Cleared Oct 02, 1998
STRYKER HIP ARTHOROSCOPY SET
K982375 · HRX
Stryker Endoscopy
Orthopedic · 87d
Cleared Oct 02, 1998
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP
K982538 · DSP
Belmont Instrument Corp.
Cardiovascular · 73d
Cleared Oct 02, 1998
OTI FEMORAL LOCK TOTAL HIP SYSTEM
K982598 · JDI
Osteoimplant Technology, Inc.
Orthopedic · 70d
Cleared Oct 02, 1998
CONTEMPORARY ACETABULAR COMPONENT
K982670 · JDI
Howmedica Corp.
Orthopedic · 63d
Cleared Oct 02, 1998
MAGNATEK 40
K982907 · DQA
Magna Advanced Technologies, Inc.
Anesthesiology · 45d
Cleared Oct 02, 1998
AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS
K982914 · MNI
Aesculap, Inc.
Orthopedic · 44d
Cleared Oct 02, 1998
TRIMETHOPRIM/SULPHAMETHOXAZOLE
K983027 · JWY
Ab Biodisk
Microbiology · 32d
Cleared Oct 01, 1998
IMX HOMOCYSTEINE
K980812 · DFC
Axis Biochemicals, Asa
Chemistry · 212d
Cleared Oct 01, 1998
UPRO
K981295 · JGQ
Abbott Laboratories
Chemistry · 175d
Cleared Oct 01, 1998
CHOLESTRON PRO II CHOLESTEROL TEST
K981345 · CHH
Lifestream Diagnostics, Inc.
Chemistry · 170d
Cleared Oct 01, 1998
VYGON DOUBLE LUMEN UMBILICAL CATHETER
K981630 · FOS
Schiff & Co.
General Hospital · 147d
Cleared Oct 01, 1998
LINER 1:HARD RELINE LIQUID
K981861 · EBI
Harry J. Bosworth Co.
Dental · 141d
Cleared Oct 01, 1998
COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT
K982848 · MRR
Roche Diagnostic Systems, Inc.
Chemistry · 50d
Cleared Oct 01, 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · DYB
Cordis Corp.
Cardiovascular · 31d
Cleared Sep 30, 1998
A1 ACOUSTIC RHINOMETER
K972140 · BXQ
G.M. Instruments , Ltd.
Anesthesiology · 481d
Cleared Sep 30, 1998
CO2 GAS WARMING UNIT (6-800-00)
K972675 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 441d