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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
126529–126552 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 03, 1990
SNAP MYCOBACTERIA AVIUM COMPLEX
K900202 · LQF
Syngene, Inc.
Microbiology · 77d
Cleared Apr 03, 1990
AVI MODEL 840 DUAL CHANNEL INFUSION PUMP
K900204 · FRN
3M Company
General Hospital · 77d
Cleared Apr 03, 1990
COULTER AMYLASE REAGENT
K900230 · JFJ
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
COULTER CALCIUM REAGENT
K900231 · CJY
Coulter Corp.
Chemistry · 76d
Cleared Apr 03, 1990
SNAP M. TUBERCULOSIS COMPLEX
K900292 · LQF
Syngene, Inc.
Microbiology · 71d
Cleared Apr 03, 1990
PREBYPASS FILTER, CAT. NO. FPB-5
K900672 · KRJ
American Omni Medical, Inc.
Cardiovascular · 49d
Cleared Apr 03, 1990
SERIAL FLOW
K900673 · BZG
Spirometrics, Inc.
Anesthesiology · 49d
Cleared Apr 03, 1990
CSF-FLOW CONTROL VALVE, CYLINDRICAL & SHUNT KIT
K900676 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 50d
Cleared Apr 03, 1990
SMU 611 UNIVERSALMONITOR
K900700 · DPS
Ppg Industries, Inc.
Cardiovascular · 50d
Cleared Apr 03, 1990
NOVAPATH MICROPLATE READER
K900776 · JJQ
Bio-Rad
Chemistry · 42d
Cleared Apr 03, 1990
ENZYMUN TEST(R) LH
K900779 · CEP
Boehringer Mannheim Corp.
Chemistry · 42d
Cleared Apr 03, 1990
TECHNICON AXON SYSTEM REAGENT METHODS
K900905 · CKA
Technicon Instruments Corp.
Chemistry · 35d
Cleared Apr 03, 1990
SPIROMETRICS MODEL 2600 MIRO SPIROMETER
K901057 · BZG
Spirometrics, Inc.
Anesthesiology · 28d
Cleared Apr 03, 1990
ENZYMUN TEST(R) INSULIN
K901135 · CFP
Boehringer Mannheim Corp.
Chemistry · 22d
Cleared Apr 03, 1990
ABC HANDPIECE ADAPTER
K901248 · HAM
Beacon Laboratories, Inc.
General & Plastic Surgery · 19d
Cleared Apr 03, 1990
CEDIA (TM) CORTISOL ASSAY
K901296 · CGR
Microgenics Corp.
Chemistry · 14d
Cleared Apr 03, 1990
VITAL SURGICAL GLOVES
K901359 · KGO
Mastervest Corp. Sdn Bhd.
General Hospital · 11d
Cleared Apr 02, 1990
WALKLITE PROTABLE RE-CHARGEABLE CURING LIGHT
K895085 · EBZ
Lustgarten Multi-Tech International,...
Dental · 231d
Cleared Apr 02, 1990
MICRORUPTOR III SYSTEM, CW ND: YAG LASER COMPONENT
K895347 · GEX
Lasag Medical Lasers
General & Plastic Surgery · 213d
Cleared Apr 02, 1990
TEMPORARY DENTAL CEMENT
K895487 · EMA
Dentsply Intl.
Dental · 213d
Cleared Apr 02, 1990
AMEDA/EGNELL DOLPHIN DISPO-SOFT VACUUM EXTRACTOR
K895700 · HDB
Hollister, Inc.
Obstetrics & Gynecology · 192d
Cleared Apr 02, 1990
DOPPLER OPTION FOR PLATINUM
K900002 · DXK
Philips Medical Systems North...
Cardiovascular · 90d
Cleared Apr 02, 1990
SPECTRASTIM 2000 MUSCLE STIMULATOR
K900029 · IPF
Therapeutic Technologies, Inc.
Physical Medicine · 89d
Cleared Apr 02, 1990
SIMULTEST IMK PLUS(TM)
K900078 · GKZ
Bd Becton Dickinson Vacutainer...
Hematology · 88d