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
65377–65400 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 20, 2005
REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING...
K051523 · LLZ
Konica Minolta Medical & Graphic, Inc.
Radiology · 42d
Cleared Jul 20, 2005
MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE
K051528 · LLZ
Mevis Technology GmbH & Co. KG
Radiology · 42d
Cleared Jul 20, 2005
INFINITY MONITORS WITH SCIO MODIFICATIONS
K051628 · MHX
Draeger Medical Systems, Inc.
Cardiovascular · 30d
Cleared Jul 20, 2005
SCAN300FP / RETROPAN (VDC)
K051664 · MUH
Oy Ajat, Ltd.
Radiology · 28d
Cleared Jul 20, 2005
MODIFICATION TO SHOULDER FIXATION SYSTEM
K051728 · LXT
Hand Innovations, LLC
Orthopedic · 23d
Cleared Jul 20, 2005
OSTEOVATION CMF BONE VOID FILLER
K051784 · GXP
Skeletal Kinetics, LLC
General & Plastic Surgery · 19d
Cleared Jul 20, 2005
MYLAB 90 ULTRASOUND IMAGING SYSTEM, MODEL 6100
K051837 · IYN
Esaote, S.P.A.
Radiology · 14d
Cleared Jul 19, 2005
IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
K041342 · MGQ
Stiefel Laboratories, Inc.
General & Plastic Surgery · 425d
Cleared Jul 19, 2005
CALC-I-OSS
K042583 · LYC
Ultradent Products, Inc.
Dental · 300d
Cleared Jul 19, 2005
DEALIGHT IPL
K043032 · GEX
Europro, Inc.
General & Plastic Surgery · 258d
Cleared Jul 19, 2005
SPIROTEL
K043528 · BZG
Mir Medical Intl. Research Srl
Anesthesiology · 210d
Cleared Jul 19, 2005
DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES
K050210 · JWH
Biomet, Inc.
Orthopedic · 172d
Cleared Jul 19, 2005
ELITE IMPLANT
K050417 · ELW
Zhermack S.P.A.
Dental · 151d
Cleared Jul 19, 2005
MEDSTAR 220, MODEL 533-220
K050951 · DXH
Cibernet Systems Corp.
Cardiovascular · 95d
Cleared Jul 19, 2005
PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE...
K051012 · JIT
Salimetrics, LLC
Chemistry · 89d
Cleared Jul 19, 2005
MARS HOLTER ANALYSIS WORKSTATION
K051026 · DQK
Ge Medical Systems Information...
Cardiovascular · 88d
Cleared Jul 19, 2005
GENEROS SB SMALL BONE DISTRACTION IMPLANT
K051162 · KTT
Orthonetx, Inc.
Orthopedic · 75d
Cleared Jul 19, 2005
HYDRALOK SYSTEM
K051216 · MNH
Altiva Corp.
Orthopedic · 68d
Cleared Jul 19, 2005
STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH POLYMER COATING AND PROTEIN...
K051329 · LYY
Siam Sempermed Corp., Ltd.
General Hospital · 60d
Cleared Jul 19, 2005
SKYLIGHT LED CURING LIGHT
K051571 · EBZ
Dmetec.Co., Ltd.
Dental · 35d
Cleared Jul 19, 2005
NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND...
K051599 · GWM
Neurorecovery, Inc.
Neurology · 33d
Cleared Jul 19, 2005
ANATOMICAL SHOULDER KEELED GLENOID
K051623 · KWS
Zimmer GmbH
Orthopedic · 29d
Cleared Jul 19, 2005
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION
K051634 · MSX
Ge Healthcare
Cardiovascular · 29d
Cleared Jul 19, 2005
EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM
K051682 · LZO
Exactech, Inc.
Orthopedic · 26d