Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
75649–75672 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 17, 2002
LACTOSORB MINI INTERFERENCE SCREW
K021254 · HWC
Biomet Orthopedics, Inc.
Orthopedic · 89d
Cleared Jul 17, 2002
INION HEXALON BIODEGRADABLE ACL/PCL SCREW
K021280 · HWC
Inion , Ltd.
Orthopedic · 86d
Cleared Jul 17, 2002
WRIST FUSION PLATE
K021321 · HRS
Acu Med, Inc.
Orthopedic · 83d
Cleared Jul 17, 2002
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
K021383 · EFW
Agion Technologies, LLC
Dental · 76d
Cleared Jul 17, 2002
ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
K021526 · LFG
ACON Laboratories, Inc.
Chemistry · 68d
Cleared Jul 17, 2002
ALBUMIN REAGENT
K021636 · CJW
Intersect Systems, Inc.
Chemistry · 61d
Cleared Jul 17, 2002
PHILIPS COMPONENT COMPACT MONITOR, RELEASE A.04, MODEL #M1275B
K021778 · DQA
Philips Medical Systems
Anesthesiology · 48d
Cleared Jul 17, 2002
DIGITAL CLINICAL THERMOMETER, MODEL KD-193
K021851 · FLL
K-Jump Health Co., Ltd.
General Hospital · 42d
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