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
86089–86112 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 04, 1999
RC CORNET, MODEL #44F50
K983308 · BWF
Pari Holding Co.
Anesthesiology · 256d
Cleared Jun 04, 1999
SURGISORB
K984374 · GAM
Samyang Corp.
General & Plastic Surgery · 179d
Cleared Jun 04, 1999
SUGITA TITANIUM ANEURYSM CLIP
K990202 · HCH
Mizuho America, Inc.
Neurology · 134d
Cleared Jun 04, 1999
SOLO ORTHO
K990743 · DYH
Sybron Dental Specialties, Inc.
Dental · 88d
Cleared Jun 04, 1999
MODIFICATION TO WOUN'DRES
K991202 · MGQ
Coloplast Corp.
General & Plastic Surgery · 74d
Cleared Jun 04, 1999
COPALIS MULTIPLEX EBV ANTIBODY ASSAY
K991660 · LSE
DiaSorin, Inc.
Microbiology · 21d
Cleared Jun 03, 1999
A P HARNESS
K981860 · KMK
Paraworks Enterprise, Ltd.
General Hospital · 372d
Cleared Jun 03, 1999
SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEM
K983996 · MHX
Spacelabs Medical, Inc.
Cardiovascular · 205d
Cleared Jun 03, 1999
XK-95 HIGH SPEED MOTOR DRILL SYSTEM
K984035 · HBE
Komet Medical
Neurology · 203d
Cleared Jun 03, 1999
METRA PS PROCEDURE KIT
K984600 · GCJ
Inlet Medical, Inc.
General & Plastic Surgery · 157d
Cleared Jun 03, 1999
AIA-PACK CA 125
K990431 · LTK
Tosoh Medics, Inc.
Immunology · 112d
Cleared Jun 03, 1999
LAMITRODE LEADS
K990469 · GZB
Advanced Neuromodulation Systems
Neurology · 107d
Cleared Jun 03, 1999
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777
K990483 · DTB
Biotronik, Inc.
Cardiovascular · 107d
Cleared Jun 03, 1999
POWDER FREE BLUE NITRILE GLOVE
K990668 · LZA
Tg Medical Sdn. Bhd.
General Hospital · 93d
Cleared Jun 03, 1999
THERMAL CAUTERY DEVICE, FORCEPS
K990728 · HQP
Starion Instruments
Ophthalmic · 90d
Cleared Jun 03, 1999
INSIGHT MILLENNIUM
K990778 · HCC
Fasstech
Neurology · 86d
Cleared Jun 03, 1999
COLORSOFT, COLOR ENHANCED TINTED SOFT CONTACT LENS
K990815 · LPL
Colorsoft Laboratories Corp.
Ophthalmic · 84d
Cleared Jun 03, 1999
AUTODOSE INFUSION SYSTEM
K990889 · MEB
Tandem Medical, Inc.
General Hospital · 78d
Cleared Jun 03, 1999
MTP HAMOU ENDOMAT DISPOSABLE TUBING SETS
K990910 · HIH
Mtp Medical Technical Promotion GmbH
Obstetrics & Gynecology · 77d
Cleared Jun 03, 1999
MTP ARTHROPUMP DISPOSABLE TUBING SET
K990911 · HRX
Mtp Medical Technical Promotion GmbH
Orthopedic · 77d
Cleared Jun 03, 1999
ORTHOGONAL EP CATHETERS
K990958 · DRF
Irvine Biomedical, Inc.
Cardiovascular · 73d
Cleared Jun 03, 1999
KSEA NEURO-FIBERSCOPE
K991069 · GWG
KARL STORZ Endoscopy-America, Inc.
Neurology · 64d
Cleared Jun 03, 1999
STERIS SMOKE EVACUATION SYSTEM
K991167 · FYD
STERIS Corporation
General Hospital · 57d
Cleared Jun 03, 1999
LC MICROFILL
K991442 · EBF
S & C Polymer GmbH
Dental · 38d