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
70753–70776 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 26, 2003
PYLORI IGG
K033067 · LYR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM
K033070 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
CHLAMYDIA IGG ELISA TEST SYSTEM
K033079 · LJC
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
K033083 · LSR
Trinity Biotech USA
Microbiology · 58d
Cleared Nov 26, 2003
DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE
K033281 · MSX
Datex-Ohmeda
Cardiovascular · 43d
Cleared Nov 26, 2003
AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12
K033292 · MOS
Igc-Medical Advances, Inc.
Radiology · 43d
Cleared Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · MSD
C.R. Bard, Inc.
Gastroenterology & Urology · 43d
Cleared Nov 26, 2003
FOSSA URETERAL OPEN LUMEN STENT
K033368 · EYB
Fossa Medical, Inc.
Gastroenterology & Urology · 36d
Cleared Nov 26, 2003
NXSTAGE PUREFLOW SOLUTION
K033386 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 34d
Cleared Nov 26, 2003
SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH...
K033411 · KTT
Synthes (Usa)
Orthopedic · 30d
Cleared Nov 26, 2003
REFLECTION CONSTRAINED LINER
K033442 · KWZ
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Nov 26, 2003
MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN...
K033482 · LON
Dade Behring, Inc.
Microbiology · 22d
Cleared Nov 26, 2003
FUJI COMPUTED RADIOGRAPHY (FCR) VELOCITY IMAGE READER
K033561 · MQB
Fujifilm Medical System U.S.A., Inc.
Radiology · 14d
Cleared Nov 25, 2003
CAPHOSOL
K030802 · LFD
Inpharma A.S.
Dental · 257d
Cleared Nov 25, 2003
MONITOR, MODEL HSM-00200
K031153 · DPW
Arrow Intl., Inc.
Cardiovascular · 228d
Cleared Nov 25, 2003
SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL,...
K031340 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 211d
Cleared Nov 25, 2003
JSA REPROCESSED COMPRESSION SLEEVE DEVICES
K031722 · JOW
Jack Speer and Assoc., Inc.
Cardiovascular · 175d
Cleared Nov 25, 2003
MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM
K031997 · BSY
Mallinckrodt Dar S.R.L.
Anesthesiology · 151d
Cleared Nov 25, 2003
DRAEGER MICRO2+ AND MASIMO MINISAT
K032537 · DQA
Draeger Medical Systems, Inc.
Anesthesiology · 99d
Cleared Nov 25, 2003
MDIFICATION TO MEDIPRIME
K033013 · LLZ
Algotec Systems, Ltd.
Radiology · 60d
Cleared Nov 25, 2003
AXIOM BIOLASER LLLT SERIES-3
K033015 · NHN
Axiom Usa., Inc.
Physical Medicine · 60d
Cleared Nov 25, 2003
GRANDIO FLOW
K033117 · EBF
Voco GmbH
Dental · 56d
Cleared Nov 25, 2003
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
K033335 · MMZ
Siemens Medical Solutions USA, Inc.
Gastroenterology & Urology · 40d
Cleared Nov 25, 2003
GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM
K033504 · LNH
General Electric Co.
Radiology · 20d