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
88009–88032 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Sep 30, 1998
HEMOCHRON JR. MIOCROCOAGULATION CITRATED PT
K972866 · GJS
International Technidyne Corp.
Hematology · 422d
Cleared Sep 30, 1998
THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG...
K973203 · DAK
Sangstat Medical Corp.
Immunology · 400d
Cleared Sep 30, 1998
OMNIFLATOR 6630(6-630-00)
K973447 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 384d
Cleared Sep 30, 1998
DUOSTAR
K974170 · GEI
Mti Corp./ Electrostar S.A.-Haiti
General & Plastic Surgery · 329d
Cleared Sep 30, 1998
AVOCET PT
K980839 · JPA
Avocet Medical, Inc.
Hematology · 210d
Cleared Sep 30, 1998
DIGITAL CLINICAL THERMOMETER, MODELS ST-833A & ST-834A
K981337 · FLL
Mesure Technology
General Hospital · 170d
Cleared Sep 30, 1998
SYSMEX AUTOMATED COAGULATION ANALYZER CA-500
K981711 · JPA
Dade Behring, Inc.
Hematology · 156d
Cleared Sep 30, 1998
SYNTHETIC EXAMINATION GLOVE, POWDERED
K981876 · LYZ
Hsing YI Plastics Processing Co, Ltd.
General Hospital · 125d
Cleared Sep 30, 1998
METRON QA-IDS I.V. PUMP TESTER
K982020 · FRN
Metron U.S., Inc.
General Hospital · 113d