FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
70153–70176 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 25, 2003
MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS
K033567 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Nov 25, 2003
ATR 5000, LC 5000, IMPLANT SYSTEM
K033597 · EKX
Advanced Technology Research (A.T.R.)...
Dental · 11d
Cleared Nov 24, 2003
IMMUNICON CELLTRACKS ANALYZER
K030263 · GKZ
Immunicon Corp.
Hematology · 301d
Cleared Nov 24, 2003
GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML
K031419 · KPE
Laboratorios Grifols, S.A.
General Hospital · 203d
Cleared Nov 24, 2003
SYNERGETICS SYNERLIGHT FIBER OPTIC LIGHTSOURCE
K032598 · MPA
Synergetics, Inc.
Ophthalmic · 91d
Cleared Nov 24, 2003
BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG
K032713 · LSR
Boston Biomedica, Inc.
Microbiology · 83d
Cleared Nov 24, 2003
CEDIA VANCOMYCIN ASSAY
K032811 · LEH
Microgenics Corp.
Toxicology · 76d
Cleared Nov 24, 2003
HBA SPERM-HYALURONAN BINDING ASSAY
K032874 · POV
Biocoat, Inc.
Hematology · 70d