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

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175,820 results
50569–50592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 28, 2010
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4
K100378 · FTC
Daavlin Distributing Co.
General & Plastic Surgery · 71d
Cleared Apr 28, 2010
PIEZOELECTRIC SYSTEM
K100410 · JDX
Satelec
Orthopedic · 71d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710 · DQX
St Jude Medical
Cardiovascular · 47d
Cleared Apr 28, 2010
PROFEMUR HIP SYSTEM MODULAR NECKS
K100866 · LZO
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Apr 27, 2010
URITEST 50 AND URITEST 500 URINE ANALYZER
K091472 · KQO
Arj Medical, Inc.
Chemistry · 344d
Cleared Apr 27, 2010
V7 PORTABLE SUCTION UNITS
K093241 · BTA
Hersill, S.L.
General & Plastic Surgery · 194d
Cleared Apr 27, 2010
POLARIS CONTACT LENS CASE
K093377 · LRX
Reliance Design & Manufacturing Corp.
Ophthalmic · 180d
Cleared Apr 27, 2010
ELECSYS FOLATE III CALCHECK 5
K094031 · JJX
Roche Diagnostics
Chemistry · 118d
Cleared Apr 27, 2010
F&P ICON SERIES CPAP
K094040 · BZD
Fisher &Paykel Healthcare , Ltd.
Anesthesiology · 118d
Cleared Apr 26, 2010
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM
K092171 · MUH
Genoray Co., Ltd.
Radiology · 279d
Cleared Apr 26, 2010
NEXUS PRESSURE RATED EXTENSION SETS
K092382 · FPA
Nexus Medical, LLC
General Hospital · 264d
Cleared Apr 26, 2010
SURESHOT TAN NAILS AND ACCESSORIES
K092748 · HSB
Smith & Nephew, Inc.
Orthopedic · 230d
Cleared Apr 26, 2010
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL...
K092911 · JJX
Diazyme Laboratories
Chemistry · 216d
Cleared Apr 26, 2010
ENDURAMESH, MODEL 762.XXX
K093207 · MQP
Lucero Medical, LLC
Orthopedic · 195d
Cleared Apr 26, 2010
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM
K093478 · MUH
Trophy
Radiology · 168d
Cleared Apr 26, 2010
CRESCENT SPINAL SYSTEM
K094025 · MAX
Medtronic Sofamor Danek
Orthopedic · 117d
Cleared Apr 26, 2010
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER
K100268 · CBF
Sechrist Industries, Inc.
Anesthesiology · 87d
Cleared Apr 26, 2010
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP
K100548 · GCJ
Covidien Lp, Formerly Registered AS...
General & Plastic Surgery · 59d
Cleared Apr 26, 2010
ELECSYS C-PEPTIDE CALCHECK 5
K100810 · JJX
Roche Diagnostics
Chemistry · 35d
Cleared Apr 23, 2010
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE
K090882 · NGT
Hospira, Inc.
General Hospital · 388d
Cleared Apr 23, 2010
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02,...
K091987 · FZP
LeMaitre Vascular, Inc.
General & Plastic Surgery · 295d
Cleared Apr 23, 2010
M
K092542 · DZE
Mediscitec, Inc.
Dental · 247d
Cleared Apr 23, 2010
ELECSYS TESTOSTERONE II IMMUNOASSAY
K093421 · CDZ
Roche Diagnostics Corp.
Chemistry · 171d
Cleared Apr 23, 2010
BILI-MIRROR MODEL BLM-1
K093618 · LBI
Physician Engineered Products, Inc.
General Hospital · 151d