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
49321–49344 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 2010
TELERADPRO
K102476 · LMA
Vidar Systems Corp.
Radiology · 38d
Cleared Oct 07, 2010
D2RF DIGITAL DYNAMIC REMOTE SYSTEM
K102529 · OWB
Stephanix Radiological Systems
Radiology · 35d
Cleared Oct 07, 2010
VOLPARA, VERSION 1.3
K102556 · LLZ
Matakina Technology Limited
Radiology · 30d
Cleared Oct 07, 2010
ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE
K102582 · JOW
Devon Medical, Inc.
Cardiovascular · 29d
Cleared Oct 07, 2010
I-LOGIC INREACH SYSTEM
K102604 · JAK
Superdimension, Ltd.
Radiology · 27d
Cleared Oct 07, 2010
ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER
K102632 · GDW
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 24d
Cleared Oct 07, 2010
ARSTASIS ACCESS SYSTEM
K102728 · DYB
Arstasis, Inc.
Cardiovascular · 15d
Cleared Oct 06, 2010
HSV STRAW
K092398 · MQK
Cryo Bio System
Obstetrics & Gynecology · 426d
Cleared Oct 06, 2010
PARADIGM INTERSPINOUS FUSION PLATE
K093438 · KWP
Paradigm Spine, LLC
Orthopedic · 336d
Cleared Oct 06, 2010
ORTHOPANTOMOGRAPH OP300
K093683 · MUH
Instrumentarium Dental, Palodex Group OY
Radiology · 310d
Cleared Oct 06, 2010
ACUMED WRIST ARTHRODESIS PLATE SYSTEM
K100123 · HRS
Acumed, LLC
Orthopedic · 264d
Cleared Oct 06, 2010
CONSENSUS CS2 PLUS ACETABULAR INSERT
K100933 · LPH
Consensus Orthopedics, Inc.
Orthopedic · 184d
Cleared Oct 06, 2010
ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES
K101760 · LZA
Profit Point Manufacturing Sdn Bhd
General Hospital · 105d
Cleared Oct 06, 2010
CRYOMEGA
K102006 · GEH
Stc Consulting, LLC
General & Plastic Surgery · 82d
Cleared Oct 06, 2010
GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION...
K102089 · LYZ
Grand Work Plastic Products Co., Ltd.
General Hospital · 62d
Cleared Oct 06, 2010
PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE...
K102092 · MSH
Prestige Ameritech
General Hospital · 71d
Cleared Oct 06, 2010
POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K102099 · LYZ
Hong DI Plastic Products Co., Ltd.
General Hospital · 71d
Cleared Oct 06, 2010
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE
K102277 · MAX
Vertebral Technologies, Inc.
Orthopedic · 56d
Cleared Oct 05, 2010
DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600
K093816 · KPR
Medien International Co, Ltd.
Radiology · 298d
Cleared Oct 05, 2010
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY...
K093893 · FGE
Idev Technologies, Inc.
Gastroenterology & Urology · 291d
Cleared Oct 05, 2010
TDS PRECISION DENTAL BAR
K100356 · NHA
Pou YU Biotechnology Co., Ltd.
Dental · 235d
Cleared Oct 05, 2010
ANTI-HAV
K100903 · LOL
Roche Professional Diagnostics
Microbiology · 187d
Cleared Oct 05, 2010
IMC SURGICAL DRAPE
K100991 · KKX
International Medsurg Connection
General Hospital · 179d
Cleared Oct 05, 2010
GE ECHOPAC MODEL BT10
K101324 · LLZ
Ge Vingmed Ultrasound AS
Radiology · 147d