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
88729–88752 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 20, 1998
DORNIER MEDILAS E
K981438 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 90d
Cleared Jul 20, 1998
INTEGRATED DRIVE/PUMP SYSTEM FOR OTOLARYNGOLOGY
K981637 · ERL
Linvatec Corp.
Ear, Nose, Throat · 73d
Cleared Jul 20, 1998
STATUSFLOW
K982231 · GKZ
R&D Systems, Inc.
Hematology · 25d
Cleared Jul 17, 1998
DUAL HOOK FIBEROPTIC DELIVERY SYSTEM
K970069 · GEX
Ihd, Inc.
General & Plastic Surgery · 555d
Cleared Jul 17, 1998
800 SERIES SURGICAL LASER SYSTEM ORION SERIES SURGICAL LASER SYSTEM ANGLED...
K972575 · GEX
Laserscope
General & Plastic Surgery · 372d
Cleared Jul 17, 1998
BMC RF CANNULA
K972846 · GXI
Baylis Medical Co., Inc.
Neurology · 350d
Cleared Jul 17, 1998
KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM
K973430 · GCJ
Eastman Kodak Company
General & Plastic Surgery · 310d
Cleared Jul 17, 1998
COLORPAC TOXIN A
K980185 · LLH
Bd Becton Dickinson Vacutainer...
Microbiology · 178d
Cleared Jul 17, 1998
CMS BLIZZARD 700 SERIES MODELS 730, 740,750,760,770,780 & 790
K980668 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 147d
Cleared Jul 17, 1998
CMS BLIZZARD 700 SERIES MODELS 710, 711, 712, 720, 721 AND 722
K980670 · GEH
Cryomedical Sciences, Inc.
General & Plastic Surgery · 147d
Cleared Jul 17, 1998
HAKIM MICRO PROGRAMMABLE VALVE SYSTEM
K980778 · JXG
Johnson & Johnson Professionals, Inc.
Neurology · 137d
Cleared Jul 17, 1998
Squirt Fluid Delivery System
K981417 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 88d
Cleared Jul 17, 1998
NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM
K981424 · IYE
Nomos Corp.
Radiology · 88d
Cleared Jul 17, 1998
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K981463 · KNF
Omnitech Systems, Inc.
Obstetrics & Gynecology · 85d
Cleared Jul 17, 1998
MULTI-PARAMETER MODULE, MODEL M3000A & DISPLAY UNIT, MODEL M3046A
K981576 · MHX
Hewlett-Packard GmbH
Cardiovascular · 74d
Cleared Jul 17, 1998
DEVILBISS MODEL 6305D HEAVY DUTY AC ASPIRATOR
K981602 · BTA
Sunrise Medical Hhg, Inc.
General & Plastic Surgery · 73d
Cleared Jul 17, 1998
NON-STERILE HOLSTER, STERILE HOLSTER MODEL ESH1-NS, ESH1, ES PENCIL W/...
K981614 · GEI
Aaron Medical Industries
General & Plastic Surgery · 72d
Cleared Jul 17, 1998
MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST,...
K981641 · IZH
Instrumentarium Corp.
Radiology · 70d
Cleared Jul 17, 1998
RADIOTHERAPEUTICS RF-2000 RADIOFREQUENCY GENERATOR
K981672 · GEI
Radiotherapeutics Corp.
General & Plastic Surgery · 66d
Cleared Jul 17, 1998
EXTERNAL FIXATION
K981716 · JDW
Avanta Orthopaedics, Inc.
Orthopedic · 63d
Cleared Jul 17, 1998
DORNIER MEDILAS H
K981718 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 63d
Cleared Jul 17, 1998
DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002
K981730 · LBB
Nk Biotechnical Corp.
Neurology · 63d
Cleared Jul 17, 1998
BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX
K981745 · DRS
Sunscope Intl., Inc.
Cardiovascular · 60d