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
88033–88056 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 18, 1998
BREATHTIQUE TONGUE SCRAPER
K983087 · LCN
Custom Medical Arts, Inc.
Dental · 76d
Cleared Nov 18, 1998
ACON MIDSTREAM PREGNANCY TEST
K983090 · LCX
ACON Laboratories, Inc.
Chemistry · 76d
Cleared Nov 18, 1998
BESURE PLUS ONE-STEP HOME OVULATION PREDICTOR KIT
K983113 · CEP
Syntron Bioresearch, Inc.
Chemistry · 75d
Cleared Nov 18, 1998
AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S...
K983168 · EFB
Ora Innovations, Inc.
Dental · 69d
Cleared Nov 18, 1998
ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES
K983174 · JXM
Roche Diagnostic Systems, Inc.
Toxicology · 69d
Cleared Nov 18, 1998
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188 · LDJ
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST METHAMPHETAMINES TEST KIT
K983189 · LAF
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST OPIATES TEST KIT
K983190 · DJG
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
DBEST COCAINE TEST KIT
K983191 · DIO
Ameritek, Inc.
Toxicology · 68d
Cleared Nov 18, 1998
ABBOTT ARCHITECT TESTOSTERONE
K983212 · CDZ
Abbott Laboratories
Chemistry · 65d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR PIXI BONE DENSITOMETERS
K983262 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · LFH
Diagnostic Reagents, Inc.
Toxicology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR EXPERT-XL BONE DENSITOMETER
K983269 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
FRACTURE RISK ASSESSMENT OPTION FOR DPX SERIES BONE DENSITOMETERS
K983271 · KGI
Lunar Corp.
Radiology · 62d
Cleared Nov 18, 1998
G/K SFN AND STN LOCKING NAILS
K983358 · HSB
Howmedica, Inc.
Orthopedic · 55d
Cleared Nov 18, 1998
PRODIGY- 3
K983370 · EBF
Sybron Dental Specialties, Inc.
Dental · 55d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN...
K983376 · LLL
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN...
K983378 · LJM
Zeus Scientific, Inc.
Immunology · 54d
Cleared Nov 18, 1998
ONTRAK TESTCUP-ER
K983388 · DIO
Roche Diagnostic Systems, Inc.
Toxicology · 54d
Cleared Nov 18, 1998
IS-ANTI-MPO IGG ELISA TEST SYSTEM
K983390 · MOB
Columbia Bioscience, Inc.
Immunology · 54d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST...
K983418 · DHR
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK...
K983420 · LKP
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED...
K983422 · LRM
Zeus Scientific, Inc.
Immunology · 50d
Cleared Nov 18, 1998
THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME...
K983423 · LLL
Zeus Scientific, Inc.
Immunology · 50d