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
91105–91128 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 02, 1997
ISO-GARD FILTER ANGLED(18212)/ISO-GARD FILTER STRAIGHT(19212)
K965016 · CAH
Gibeck, Inc.
General Hospital · 351d
Cleared Dec 02, 1997
OHMEDA INFANT RESUSCITATION SYSTEM
K971243 · BTM
Ohmeda Medical
Anesthesiology · 243d
Cleared Dec 02, 1997
FUKUDA DENSHI MODEL FCP-2155 MULTI CHANNEL, INTERPRETIVE ELECTROCARDIOGRAPH
K971440 · LOS
Fukuda Denshi USA, Inc.
Cardiovascular · 228d
Cleared Dec 02, 1997
QUANTA LITE TOXOPLASMA IGG
K971441 · LGD
Inova Diagnostics, Inc.
Microbiology · 228d
Cleared Dec 02, 1997
ACCUDEXA BONE DENSITOMETER
K971735 · KGI
Schick Technologies, Inc.
Radiology · 204d
Cleared Dec 02, 1997
QUICKIE P90 SERIES
K972230 · ITI
Quickie Designs, Inc.
Physical Medicine · 172d
Cleared Dec 02, 1997
FOUNDATION POROUS HIP STEM
K973302 · LPH
Encore Orthopedics, Inc.
Orthopedic · 90d
Cleared Dec 02, 1997
MVM 3.3 MM MICROENDOSCOPE
K973304 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 90d
Cleared Dec 02, 1997
THERAPAX DXT 300 MODEL HF-300
K973315 · JAD
Pantak, Inc.
Radiology · 90d
Cleared Dec 02, 1997
BACT/ALERT FAN CULTURE BOTTLES
K973325 · MDB
Organon Teknika Corp.
Microbiology · 89d
Cleared Dec 02, 1997
ALCON MULTI-PURPOSE DISINFECTING SOLUTION ID 90746
K973332 · LPN
Alcon Laboratories
Ophthalmic · 89d
Cleared Dec 02, 1997
BONDING BASE
K973353 · DZE
Straumann USA
Dental · 88d
Cleared Dec 02, 1997
AQUAPLAST PALATAL STENT
K973370 · EMA
Wfr/Aquaplast Corp.
Dental · 85d
Cleared Dec 02, 1997
CURVILINEAR SUTURE PLACEMENT SYSTEM
K973415 · GCJ
Laurus Medical Corp.
General & Plastic Surgery · 84d
Cleared Dec 02, 1997
OLICON IMAGING SYSTEMS, INC. ARCHIVE SYSTEMS, NT ARCHIVE, 02ARCHIVE, ARCHIVE
K973463 · LMB
O Tech, Inc.
Radiology · 81d
Cleared Dec 02, 1997
CHIN DISTRACTOR
K973484 · JEY
Howmedica, Inc.
Dental · 78d
Cleared Dec 02, 1997
SPECTRASCIENCE REUSABLE BIOPSY FORCEPS
K973611 · FCL
Spectrascience, Inc.
Gastroenterology & Urology · 71d
Cleared Dec 01, 1997
MEDI-DX 7000
K964622 · LLN
Neuro-Diagnostic Assoc.
Neurology · 378d
Cleared Dec 01, 1997
THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
K964703 · MOI
Bayer Corp.
Immunology · 374d
Cleared Dec 01, 1997
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · GKZ
Becton Dickinson Immunocytometry Systems
Hematology · 244d
Cleared Dec 01, 1997
QUANTA LITE CMV IGG ELISA
K971335 · LFZ
Inova Diagnostics, Inc.
Microbiology · 235d
Cleared Dec 01, 1997
MICROCON 800MUV, MICROCON 400MUV, MICROCON EXC-BUV
K972064 · FRA
Biological Controls, Inc.
General Hospital · 181d
Cleared Dec 01, 1997
INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450
K972112 · GBW
Taut, Inc.
General & Plastic Surgery · 179d
Cleared Dec 01, 1997
MONOCOL/LEX-IM TEST
K972457 · KTN
Immunostics Inc.,
Immunology · 153d