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
51817–51840 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 13, 2009
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET
K093032 · JJY
Biosite Incorporated
Chemistry · 45d
Cleared Nov 13, 2009
MAGNUM NAIL
K093089 · HSB
Robert Reid, Inc.
Orthopedic · 43d
Cleared Nov 13, 2009
POWERCROSS .018 OTW PTA DILATION CATHETER
K093286 · LIT
Ev3, Inc.
Cardiovascular · 24d
Cleared Nov 12, 2009
VIZTEK WL
K091752 · KPR
Viztek, Inc.
Radiology · 149d
Cleared Nov 12, 2009
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505
K092246 · LHI
Nipro Medical Corporation
General Hospital · 107d
Cleared Nov 12, 2009
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL
K092501 · EBF
Novocol, Inc.
Dental · 90d
Cleared Nov 12, 2009
CENTROS CHRONIC HEMODIALYSIS CATHETER SET
K092597 · MSD
Ash Access Technology, Inc.
Gastroenterology & Urology · 80d
Cleared Nov 12, 2009
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL
K092826 · FRO
American Biotech Labs
General & Plastic Surgery · 59d
Cleared Nov 12, 2009
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED...
K093169 · FYA
A Plus International, Inc.
General Hospital · 36d
Cleared Nov 12, 2009
AMID STAPLER
K093253 · GDW
Safestitch, LLC
General & Plastic Surgery · 27d
Cleared Nov 12, 2009
AUTOSUTURE EEA ORVIL
K093402 · GDW
Surgical Devices, A Global Business...
General & Plastic Surgery · 10d
Cleared Nov 12, 2009
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE
K093408 · GAM
Surgical Devices, A Division of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 12, 2009
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY
K093410 · GDW
Surgical Devices, A Divsion of Tyco...
General & Plastic Surgery · 10d
Cleared Nov 10, 2009
BARD SACROCOLPOPEXY GRAFT
K090739 · OTO
C.R. Bard, Inc.
Obstetrics & Gynecology · 235d
Cleared Nov 10, 2009
BESMED JET NEBULIZER BOTTLE SET
K091272 · CAF
Besmed Health Business Corp
Anesthesiology · 194d
Cleared Nov 10, 2009
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM
K092434 · DZE
Sterngold
Dental · 95d
Cleared Nov 10, 2009
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A
K092487 · GEI
Barrx Medical, Incorporated
General & Plastic Surgery · 89d
Cleared Nov 10, 2009
COLOR LCD MONITOR, MODEL RADIFORCE MX241W
K092741 · LLZ
Eizo Nanao Corporation
Radiology · 63d
Cleared Nov 10, 2009
SAFERSONIC SONOGRAPHY COVER
K092858 · ITX
Safersonic Medizinprodukte GmbH
Radiology · 55d
Cleared Nov 10, 2009
ELECSYS TOXO IGG CALCHECK 5
K092888 · JJX
Roche Diagnostics Corp.
Microbiology · 50d
Cleared Nov 10, 2009
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4
K092899 · LNH
Ningbo Xingaoyi Magnetism Co., Ltd.
Radiology · 50d
Cleared Nov 10, 2009
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · KNG
Edan Instruments, Inc.
Radiology · 43d
Cleared Nov 10, 2009
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK,...
K093068 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 41d
Cleared Nov 10, 2009
ETHICON ENDO-SURGERYOPTICAL DILATOR
K093236 · KNQ
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 26d