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
74545–74568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 16, 2002
COBAS INTEGRA ONLINE DAT II METHADONE II
K021512 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
Cleared Jul 16, 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515 · CHL
Medica Corp.
Chemistry · 67d
Cleared Jul 16, 2002
BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301
K021736 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 49d
Cleared Jul 16, 2002
AART SILICONE CARVING BLOCK
K021820 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 42d
Cleared Jul 16, 2002
AART GLUTEAL IMPLANT
K021839 · MIB
Aesthetic and Reconstructive...
General & Plastic Surgery · 42d
Cleared Jul 16, 2002
TAGG DISPOSABLE VAGINAL SPECULUM
K021849 · HIB
Tagg Industries
Obstetrics & Gynecology · 41d
Cleared Jul 16, 2002
LUNGCARE CT SOFTWARE PACKAGE
K022013 · JAK
Siemens Medical Solutions USA, Inc.
Radiology · 26d
Cleared Jul 16, 2002
LYPHOCHEK WHOLE BLOOD CONTROL, MODELS 561, 562, 563
K022041 · JJY
Bio-Rad Laboratories, Inc.
Immunology · 22d
Cleared Jul 16, 2002
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER
K022083 · CFN
The Binding Site, Ltd.
Immunology · 20d
Cleared Jul 16, 2002
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000
K022149 · DPS
Cambridge Heart, Inc.
Cardiovascular · 14d
Cleared Jul 16, 2002
HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS
K022152 · DPS
Cambridge Heart, Inc.
Cardiovascular · 14d
Cleared Jul 15, 2002
VISION SCIENCES ENDOSHEATH SYSTEM
K012543 · EOB
Vision-Sciences, Inc.
Ear, Nose, Throat · 342d
Cleared Jul 15, 2002
ARM AUTOMATIC REPROCESSING MACHINE
K013713 · LIF
Alcavis International Incorporated
Gastroenterology & Urology · 249d
Cleared Jul 15, 2002
LIVESURE HCG URINARY PREGNANCY TEST STRIP AND TEST CARD
K020968 · JHI
Pan Probe Biotech, Inc.
Chemistry · 111d
Cleared Jul 15, 2002
EMT-CPAP
K021520 · BTL
Emergency Medical Techology
Anesthesiology · 66d
Cleared Jul 15, 2002
PHFW-10
K021592 · ITI
Pihsiang Machinery Mfg. Co., Ltd.
Physical Medicine · 61d
Cleared Jul 15, 2002
SPI ONETIME DENTAL IMPLANT
K022038 · DZE
Paxmed International
Dental · 21d
Cleared Jul 13, 2002
ZIP OPEN FORCEPS WITH ELECTROSURGICAL CUT
K020585 · GEI
Gyrus Medical, Inc.
General & Plastic Surgery · 141d
Cleared Jul 13, 2002
AMMONIA ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM
K021151 · JIF
Bayer Diagnostics Corp.
Chemistry · 94d
Cleared Jul 13, 2002
ULTRAQUIET
K021202 · KLW
Sound Technique System, LLC
Ear, Nose, Throat · 88d
Cleared Jul 13, 2002
SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
K021311 · KXK
Cp Medical
Radiology · 79d
Cleared Jul 13, 2002
BACTEC MGIT 960 PZA KIT
K021582 · MJA
Becton, Dickinson & CO
Microbiology · 60d
Cleared Jul 12, 2002
MEDX 1000 SERIES
K020017 · ILY
Medx Electronics, Inc.
Physical Medicine · 190d
Cleared Jul 12, 2002
MEDICAL ADMINISTRATOR
K020073 · LLZ
Barco N.V.
Radiology · 184d