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

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176,076 results
60505–60528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 29, 2007
ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
K063433 · IYO
Meda , Ltd.
Radiology · 77d
Cleared Jan 29, 2007
POLYSORB* SYNTHETIC ABSORBABLE SUTURE WITH MODIFIED PACKAGING
K063536 · GAM
Tyco Healthcare Group
General & Plastic Surgery · 68d
Cleared Jan 29, 2007
LUMINEX LL LASER SYSTEM
K063574 · NHN
Medical Laser Systems, Inc.
Physical Medicine · 61d
Cleared Jan 29, 2007
COAGUCHEK XS PT CONTROLS
K063823 · GGN
Roche Diagnostics Corp.
Hematology · 34d
Cleared Jan 29, 2007
POWDER FREE (YELLOW) VINYL PATIENT EXAMINATION
K070044 · LYZ
Shijiazhuang Lianhe Shunda Plastic...
General Hospital · 26d
Cleared Jan 29, 2007
ENSEAL PTC TRIO
K070165 · GEI
Surgrx, Inc.
General & Plastic Surgery · 11d
Cleared Jan 26, 2007
ANSPACH IMRI SAFE SURGICAL DRILL SYSTEM
K061297 · HBB
The Anspach Effort, Inc.
Neurology · 262d
Cleared Jan 26, 2007
TECO MICROALBUMIN 2-1 COMBO STRIPS
K061419 · JIR
Teco Diagnostics
Chemistry · 249d
Cleared Jan 26, 2007
OSFERION
K061499 · MQV
Olympus America, Inc.
Orthopedic · 240d
Cleared Jan 26, 2007
EZLASE
K061898 · GEX
Biolase Technology, Inc.
General & Plastic Surgery · 207d
Cleared Jan 26, 2007
VECTRA GENISYS VMS FR
K062354 · IPF
Encore Medical, L.P.
Physical Medicine · 165d
Cleared Jan 26, 2007
TISSUE SITE MARKING SYSTEM
K062528 · NEU
Suros Surgical Systems, Inc.
General & Plastic Surgery · 150d
Cleared Jan 26, 2007
K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING
K062535 · NUC
Mcneil-Ppc, Inc.
Obstetrics & Gynecology · 150d
Cleared Jan 26, 2007
ERBE MONOPOLAR ATTACHMENT FOR HELIX HYDRO-JET, MODEL P/N 20139-094
K062712 · GEI
Erbe USA, Inc.
General & Plastic Surgery · 137d
Cleared Jan 26, 2007
ASTRAGUARD PULMONARY FUNCTION FILTER
K062913 · BZG
Sdi Diagnostics, Inc.
Anesthesiology · 121d
Cleared Jan 26, 2007
DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL...
K063272 · JZG
Dade Behring, Inc.
Immunology · 88d
Cleared Jan 26, 2007
CIRRUS HD-OCT, MODEL 4000
K063378 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 79d
Cleared Jan 26, 2007
LIFEPAK 12 DEFIBRILLATOR/MONITOR
K063510 · MKJ
Medtronic Emergency Response Systems,...
Cardiovascular · 67d
Cleared Jan 26, 2007
ON-Q, PAINBUSTER, C-BLOC, SELECT-A-FLOW, ONDEMAND, HOMEPUMP, ECLIPSE,...
K063530 · MEB
I-Flow Corp.
General Hospital · 65d
Cleared Jan 26, 2007
EZ-MIO STERNAL
K063567 · FMI
Vidacare Corporation
General Hospital · 59d
Cleared Jan 26, 2007
ATRICURE ABLATION SYSTEM
K063630 · GEI
AtriCure, Inc.
General & Plastic Surgery · 51d
Cleared Jan 26, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819 · DQX
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 26, 2007
EIGEN DSA 2000
K063846 · LLZ
Eigen
Radiology · 30d
Cleared Jan 26, 2007
AUTO-FILL SYRINGE KIT, MODEL 7600
K063851 · FMF
Vascular Solutions, Inc.
General Hospital · 29d