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
84529–84552 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 09, 1999
MENISCUS ARROW, MODELS 531110, 531113, 531116
K993453 · MAI
Bionx Implants, Ltd.
Orthopedic · 27d
Cleared Nov 09, 1999
WAKO L-TYPE TRIGLYCERIDE TEST
K993466 · CDT
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
WAKO L-TYPE UA F TEST
K993469 · KNK
Wako Chemicals USA, Inc.
Chemistry · 27d
Cleared Nov 09, 1999
BILIBLANKET PLUS HIGH OUTPUT PHOTOTHERAPY SYSTEM
K993712 · FMZ
Ohmeda Medical
General Hospital · 6d
Cleared Nov 08, 1999
ISOBAR SEMI-RIGID SPINAL SYSTEM
K991326 · MNI
Scien'Tx USA, Inc.
Orthopedic · 203d
Cleared Nov 08, 1999
TITANIUM HARTSHILL SYSTEM
K991662 · KWP
Surgicraft , Ltd.
Orthopedic · 178d
Cleared Nov 08, 1999
ADI 9000/9001 ARTHROSCOPE AND ACCESSORIES
K992621 · HRX
Advanced Diagnostics & Interventions
Orthopedic · 95d
Cleared Nov 08, 1999
HP VIRIDIA CMS PATIENT MONITOR WITH EEG PARAMETER, MODEL M1027A
K992674 · MHX
Hewlett-Packard GmbH
Cardiovascular · 90d
Cleared Nov 08, 1999
EVENT ALLERGEN BARRIERS, EVENT MATTRESS ENCASING, EVENT DUVET ENCASING, EVENT...
K992702 · FMW
Allergy Direct
General Hospital · 88d
Cleared Nov 08, 1999
ISOBAR SPINAL SYSTEM
K992738 · MNI
Encore Orthopedics, Inc.
Orthopedic · 87d
Cleared Nov 08, 1999
LORENZ SMALL FRAGMENT SYSTEM
K992961 · HRS
Walter Lorenz Surgical, Inc.
Orthopedic · 67d
Cleared Nov 08, 1999
DIGIT WIDGET
K992970 · JDW
Hand Biomechanics Lab, Inc.
Orthopedic · 66d
Cleared Nov 08, 1999
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · LCX
Phamatech
Chemistry · 48d
Cleared Nov 08, 1999
DORNIER SCANNER HANDPIECE
K993146 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 49d
Cleared Nov 08, 1999
CASTLE SURGICAL LIGHT, MODEL 3000
K993242 · FSY
Getinge/Castle, Inc.
General & Plastic Surgery · 42d
Cleared Nov 08, 1999
HP M2600A VIRIDIA TELEMETRY SYSTEM
K993516 · DSI
Hewlett-Packard Co.
Cardiovascular · 21d
Cleared Nov 05, 1999
MONOLYTH C 600 AND 1200 HOLLOW FIBER MEMBRANE LUNG WITH INTEGRATED SOFTSHELL...
K990103 · DTZ
Sorin Biomedical, Inc.
Cardiovascular · 297d
Cleared Nov 05, 1999
DELSONIC 2000
K990546 · ELC
Sds Dental, Inc.
Dental · 256d
Cleared Nov 05, 1999
WORLDWIDE MEDICAL TECHNOLOGIES SEEDING SPACERS
K991344 · KXK
Worldwide Medical Technologies, LLC
Radiology · 200d
Cleared Nov 05, 1999
ULTRA-CBX
K991486 · DWZ
Medcanica, Inc.
Cardiovascular · 191d
Cleared Nov 05, 1999
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · DRF
C.R. Bard, Inc.
Cardiovascular · 113d
Cleared Nov 05, 1999
PLUG 'N VIEW 3D, VERSION 1.0
K992654 · LLZ
Voxar Limited
Radiology · 88d
Cleared Nov 05, 1999
DEPUY TOTAL ELBOW SYSTEM
K992656 · JDC
DePuy Orthopaedics, Inc.
Orthopedic · 88d
Cleared Nov 05, 1999
URF DIGITAL - OT
K992660 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 88d