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
61009–61032 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2006
DEL-IMS
K063188 · LLZ
Del Medical Imaging Corp.
Radiology · 41d
Cleared Nov 30, 2006
21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)
K063197 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)
K063198 · LLZ
Totoku Electric Co., Ltd.
Radiology · 41d
Cleared Nov 30, 2006
MAPMATE
K063277 · DQK
Ep Medsystems, Inc.
Cardiovascular · 30d
Cleared Nov 30, 2006
MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS,...
K063312 · DQO
Boston Scientific Corp
Radiology · 28d
Cleared Nov 30, 2006
MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS
K063342 · MOS
Medrad, Inc.
Radiology · 24d
Cleared Nov 30, 2006
EMG AC/DC SUCTION UNIT
K063448 · JCX
Emg Technology Co., Ltd.
General & Plastic Surgery · 15d
Cleared Nov 30, 2006
SYNGO NEURO PBV CT
K063507 · JAK
Siemens AG
Radiology · 10d
Cleared Nov 29, 2006
ARTHREX INTERFERENCE SCREW
K062466 · MAI
Arthrex, Inc.
Orthopedic · 97d
Cleared Nov 29, 2006
OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM
K062581 · JLW
Olympus America, Inc.
Chemistry · 90d
Cleared Nov 29, 2006
CADD-SENTRY PRO MEDICATION SAFETY SOFTWARE
K062592 · FRN
Smiths Medical MD, Inc.
General Hospital · 89d
Cleared Nov 29, 2006
ULTICARE DISPOSABLE SYRINGES AND NEEDLES
K062702 · FMF
Ultimed, Inc.
General Hospital · 79d
Cleared Nov 29, 2006
SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM...
K062749 · NHA
Nobel Biocare AB
Dental · 76d
Cleared Nov 29, 2006
BLUESHINE LIGHT SHINE SYSTEMS, SP, TWIN AND COMPACT SP
K063060 · GEX
Blueshine Srl
General & Plastic Surgery · 55d
Cleared Nov 29, 2006
OMNIGUIDE ZERO FLOW ZF-T 150 WAVEGUIDE FIBER
K063141 · GEX
Omniguide, Inc.
General & Plastic Surgery · 44d
Cleared Nov 29, 2006
LIGASURE ADVANCE LAPAROSCOPIC SEALER/DIVIDER WITH DISSECTING ELECTRODE,...
K063195 · GEI
Valleylab
General & Plastic Surgery · 40d
Cleared Nov 29, 2006
NOVATION SPLINED RDD FEMORAL STEMS
K063279 · LZO
Exactech, Inc.
Orthopedic · 29d
Cleared Nov 29, 2006
STIMULATING BUR GUARD
K063305 · ETN
Medtronic Xomed, Inc.
Ear, Nose, Throat · 28d
Cleared Nov 28, 2006
OMNIPICC P.I.
K062579 · LJS
Rita Medical Systems, Inc.
General Hospital · 89d
Cleared Nov 28, 2006
DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
K062812 · EFB
Thunder Tiger Corp.
Dental · 70d
Cleared Nov 28, 2006
AURORA
K063003 · EBZ
Parkell, Inc.
Dental · 57d
Cleared Nov 28, 2006
REGEN BIOCEMENT
K063010 · LYC
Steiner Laboratories
Dental · 57d
Cleared Nov 28, 2006
SIGNATURE EDITION GOLD INFUSION SYSTEM, MODEL 7X3X
K063288 · FRN
Cardinal Health 303,Inc.
General Hospital · 27d
Cleared Nov 28, 2006
CAAS QCA 3D
K063344 · LLZ
Pie Medical Imaging BV
Radiology · 22d