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
37849–37872 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 23, 2014
RS ORANGE NITRILE MEDICAL EXAMINATION GLOVES (POWDER FREE)
K133193 · LZA
Riverstone Resources Sdn Bhd
General Hospital · 249d
Cleared Jun 23, 2014
CLIQ DV-300 ASPIRATOR
K140809 · JCX
Ding Hwa Co., Ltd.
General & Plastic Surgery · 83d
Cleared Jun 23, 2014
SUPOLENE
K141072 · GAT
Resorba Medical GmbH
General & Plastic Surgery · 59d
Cleared Jun 23, 2014
LIQUICHEK TUMOR MARKER CONTROL
K141073 · JJY
Bio-Rad Laboratories
Immunology · 59d
Cleared Jun 23, 2014
APTUS ULNA SHORTENING 2.5
K141232 · HRS
Medartis AG
Orthopedic · 41d
Cleared Jun 20, 2014
SERVO-I VENTILATOR SYSTEM
K123149 · CBK
Maquet Critical Care AB
Anesthesiology · 623d
Cleared Jun 20, 2014
INOGEN AT HOME OXYGEN CONCENTRATOR (AKA INOGEN AT HOME)
K132489 · CAW
Inogen, Inc.
Anesthesiology · 316d
Cleared Jun 20, 2014
ENCOMPASS 10/12 HIP STEM
K132697 · LPH
Ortho Development Corp.
Orthopedic · 295d
Cleared CT Jun 20, 2014
DIAPHRAGMATIC HERNIA GRAFT
K133011 · OWV
Cook Biotech, Inc.
General & Plastic Surgery · 268d
Cleared Jun 20, 2014
DISCOVERY SYSTEM
K133062 · HJO
Innovative Visual Systems
Ophthalmic · 266d
Cleared Jun 20, 2014
BRACCO INJEENERING TRANSFER SET
K133147 · PQH
Bracco Injeneering S.A.
General Hospital · 246d
Cleared Jun 20, 2014
ADMIRE
K133646 · JAK
Siemens Medical Systems, Inc.
Radiology · 205d
Cleared Jun 20, 2014
THERMEDX FLUID MANAGMENT SYSTEM
K133799 · HIG
Thermedx, LLC
Obstetrics & Gynecology · 189d
Cleared Jun 20, 2014
PERSEUS A500
K133886 · BSZ
Draeger Medical GmbH
Anesthesiology · 182d
Cleared CT Jun 20, 2014
ULTHERA SYSTEM
K134032 · OHV
Ulthera, Inc.
General & Plastic Surgery · 171d
Cleared Jun 20, 2014
VERIGENE ENTERIC PATHOGEN NUCLEIC ACID TEST ( EP)
K140083 · PCH
Nanosphere, Inc.
Microbiology · 158d
Cleared Jun 20, 2014
SECURE-GARD SURGICAL AND PROCEDURE FACE MASK
K140155 · FXX
Cardinal Health200, LLC
General Hospital · 149d
Cleared Jun 20, 2014
SOMNODENT FUSION, CLASSIC
K140278 · LRK
Somnomed, Inc.
Dental · 137d
Cleared Jun 20, 2014
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU)...
K140610 · LZA
Hartalega NGC Sdn. Bhd.
General Hospital · 102d
Cleared Jun 20, 2014
SUREFLEX LITHOTRIPSY LASER FIBERS
K140679 · GEX
American Medical Systems
General & Plastic Surgery · 94d
Cleared Jun 20, 2014
COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM...
K140711 · LZU
Paragon Bioteck, Inc.
Ophthalmic · 91d
Cleared Jun 20, 2014
AXSOS 3 TI LOCKING PLATE SYSTEM
K141121 · HRS
Stryker Trauma AG
Orthopedic · 51d
Cleared Jun 20, 2014
VITEK 2 AST GP CEFTAROLINE
K141149 · LON
bioMerieux, Inc.
Microbiology · 46d
Cleared Jun 20, 2014
QUENTRY DOSE REVIEW
K141199 · LLZ
Brainlab AG
Radiology · 42d