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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
175,820 results
51073–51096 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 24, 2010
UCP RAPID DRUG SCREENING BUPRENORPHINE, AMP 300, MAMP 500, COC 150 TEST
K091612 · DJG
Ucp Biosciences, Inc.
Toxicology · 266d
Cleared Feb 24, 2010
CLEARVIEW EXACT PBP2A TEST, MODEL 891-000
K091766 · MYI
Binax, Inc.
Microbiology · 252d
Cleared Feb 24, 2010
CLAYTON INTRA-AURAL DEVICE (CID)
K091880 · MQC
Ascentia Health Incorporated
Dental · 245d
Cleared Feb 24, 2010
12SL ECG ANALYSIS PROGRAM
K092369 · MHX
Ge Medical Systems Information...
Cardiovascular · 203d
Cleared Feb 24, 2010
EASYMAX V SELF MONITORING BLOOD GLUCOSE SYSTEM
K092894 · NBW
Eps Bio Technology Corp.
Chemistry · 156d
Cleared Feb 24, 2010
FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER
K093026 · DYB
Footprint Medical
Cardiovascular · 148d
Cleared Feb 24, 2010
GYRUS ACMI PK BUTTON ELECTRODE
K093181 · FAS
Gyrus Acmi, Inc.
Gastroenterology & Urology · 139d
Cleared Feb 24, 2010
POWERPUMP ARTHROSCOPY SYSTEM
K093409 · HRX
Medical Vision AB
Orthopedic · 114d
Cleared Feb 24, 2010
MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA
K093425 · OLO
Mako Surgical Corp.
Orthopedic · 113d
Cleared Feb 24, 2010
BASESENS BLOOD GLUCOSE MONITORING SYSTEM
K093475 · NBW
Hygeia, Inc.
Chemistry · 110d
Cleared Feb 24, 2010
TRAXCESS DOCKING WIRE
K093647 · DQX
MicroVention, Inc.
Cardiovascular · 91d
Cleared Feb 24, 2010
DD BIO Z AND DD BIO Z - TRANSPA
K093748 · EIH
Dental Direkt of Amerika UG...
Dental · 82d
Cleared Feb 24, 2010
CL-DC20, CL-DC21
K093751 · EBZ
Good Doctors Co., Ltd.
Dental · 79d
Cleared Feb 24, 2010
VERSAPULSE MODEL P20 LASER SYSTEM
K100228 · GEX
Lumenis, Inc.
General & Plastic Surgery · 29d
Cleared Feb 24, 2010
FLEXIMARC, MODEL CM-0.9-2-10-GG-L
K100267 · IYE
Cortex Manufacturing, Inc.
Radiology · 26d
Cleared Feb 23, 2010
MEP-90 HAIR GROWTH STIMULATION SYSTEM
K091496 · OAP
Midwest Rf, LLC
General & Plastic Surgery · 279d
Cleared Feb 23, 2010
AESKULISA MPO, MODEL 30-7303US
K091860 · MOB
Aesku Diagnostics
Immunology · 249d
Cleared Feb 23, 2010
TIDI FACEMASK
K092580 · FXX
Tidi Products,Llc
General Hospital · 186d
Cleared Feb 23, 2010
POWDERED LATEX EXAMINATION GLOVES, NON-STERILE
K092681 · LYY
Khai Hoan Joint Stock Company
General Hospital · 175d
Cleared Feb 23, 2010
SKIN BARRIER FILM
K092712 · KMF
Lodestar Products, Inc.
General & Plastic Surgery · 173d
Cleared Feb 23, 2010
ARTHROSTEER ABLATOR & COAGULATOR, MODELS: REF 1070 & 1080
K093086 · GEI
Orthodynamix, LLC
General & Plastic Surgery · 145d
Cleared Feb 23, 2010
SYNGO.PET&CT ONCOLOGY
K093621 · LLZ
Siemens Medical Solutions USA, Inc.
Radiology · 92d
Cleared Feb 23, 2010
URESIL GASTROSTOMY CATHETER KIT , MODEL GCL-630HBK
K093653 · KNT
Uresil, LLC
Gastroenterology & Urology · 90d
Cleared Feb 23, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES (YELLOW, WHITE)
K093797 · LYZ
Supermax Plastic Products Co., Ltd.
General Hospital · 75d