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
75049–75072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2002
HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2
K021967 · MQP
Implex Corp.
Orthopedic · 30d
Cleared Jul 16, 2002
BICAP COAG BIPOLAR LAPAROSCOPY PROBE, MODEL 006908-910
K012018 · GEI
Acmi Corporation
General & Plastic Surgery · 383d
Cleared Jul 16, 2002
DEVILBISS SLEEP RECORDER MODEL # RM60
K012437 · MNR
Sunrise Medical Hhg, Inc.
Anesthesiology · 350d
Cleared Jul 16, 2002
AUTOSET SPIRIT CPAP SYSTEM
K013843 · BZD
ResMed Corp
Anesthesiology · 238d
Cleared Jul 16, 2002
AVID-NIT NERVE STIMULATION NEEDLES
K014246 · CAZ
Avid N.I.T., Inc.
Anesthesiology · 202d
Cleared Jul 16, 2002
INFANT FEEDING TUBES
K020005 · KNT
Promedic, Inc.
Gastroenterology & Urology · 195d
Cleared Jul 16, 2002
THE DIVACUP MENSTRUAL SOLUTION
K021356 · HHE
Diva International, Inc.
Obstetrics & Gynecology · 78d
Cleared Jul 16, 2002
INSEMINATION CATHETER, MODEL 320301
K021438 · MFD
Labotect Labor-Technik Gottingen
Obstetrics & Gynecology · 71d
Cleared Jul 16, 2002
ONLINE DAT II METHADONE II
K021505 · DJR
Roche Diagnostics Corp.
Toxicology · 68d
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