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
85849–85872 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 28, 1999
SYNERGY ADJUSTABLE LENGTH ROD
K990057 · MNI
Interpore Cross Intl.
Orthopedic · 172d
Cleared Jun 28, 1999
BIONIKE AQ BARBITURATE TEST
K990280 · DIS
Bionike, Inc.
Toxicology · 151d
Cleared Jun 28, 1999
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL...
K990705 · DYB
Medamicus, Inc.
Cardiovascular · 116d
Cleared Jun 28, 1999
POLYSLIT IFE KIT
K990998 · CFF
Helena Laboratories
Immunology · 95d
Cleared Jun 28, 1999
GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES
K991000 · LPL
Wesley Jessen Corp.
Ophthalmic · 96d
Cleared Jun 28, 1999
DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING
K991061 · NAE
Dermaphylyx, Inc.
General & Plastic Surgery · 90d
Cleared Jun 28, 1999
THE ACME MEDICAL AESTHETIC ND:YAG LASER
K991234 · GEX
Acme Medical, Inc.
General & Plastic Surgery · 77d
Cleared Jun 28, 1999
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · JDI
Biomet, Inc.
Orthopedic · 14d
Cleared Jun 27, 1999
OVERLANDER PEV 2000
K983497 · ITI
Raye'S, Inc.
Physical Medicine · 265d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST
K984343 · MXJ
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST
K984346 · LGC
Meridian Diagnostics, Inc.
Microbiology · 203d
Cleared Jun 25, 1999
SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988...
K984508 · DZA
W&H Dentalwerk Buermoos GmbH
Dental · 189d
Cleared Jun 25, 1999
INDEPENDENCE 624
K990122 · ITI
Eagle Parts & Products, Inc.
Physical Medicine · 163d
Cleared Jun 25, 1999
INDEPENDENCE 324
K990484 · ITI
Eagle Parts & Products, Inc.
Physical Medicine · 129d
Cleared Jun 25, 1999
6F HYDROLYSER THROMBECTOMY CATHETER
K990771 · QEZ
Cordis Corp.
Cardiovascular · 108d
Cleared Jun 25, 1999
ASH ADVANTAGE PERITONEAL CATHETER
K991042 · FJS
Janin Group, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 25, 1999
ASTRA TECH IMPLANTS - DENTAL SYSTEM: NEW FIXTURES (MICROMACRO)
K991053 · DZE
Astra Tech, Inc.
Dental · 87d
Cleared Jun 25, 1999
FRAMELESS NEUROMATE
K991081 · HAW
Integrated Surgical Systems, Inc.
Neurology · 86d
Cleared Jun 25, 1999
ARROW FWD POWER WHEELCHAIR
K991168 · ITI
Invacare Corp.
Physical Medicine · 79d
Cleared Jun 25, 1999
FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION
K991257 · LLZ
Fujifilm Medical System U.S.A., Inc.
Radiology · 73d
Cleared Jun 25, 1999
MODIFICATION OF ENCORE LINEAR POROUS COATED HIP
K991325 · LPH
Encore Orthopedics, Inc.
Orthopedic · 67d
Cleared Jun 25, 1999
DAUM MRI/CONVENTIONAL BIOPSY KIT
K991366 · KNW
Daum GmbH
Gastroenterology & Urology · 66d
Cleared Jun 25, 1999
HERMES CONTROL CENTER, WITH CONTROL OF THE AESOP 3000HR (HERMES READY).
K991444 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 60d
Cleared Jun 25, 1999
ORTHOSLICE OS1000 SERIES
K991455 · EHD
Trophy Radiologie
Radiology · 60d