FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
69649–69672 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 24, 2003
MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM
K033492 · MHX
Ge Medical Systems Information...
Cardiovascular · 20d
Cleared Nov 24, 2003
ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER
K033548 · KHE
Roche Diagnostics Corp.
Chemistry · 12d
Cleared Nov 24, 2003
SMART OFFSET STAPES PISTON
K033554 · ETB
Gyrus Ent LLC
Ear, Nose, Throat · 12d
Cleared Nov 21, 2003
CONTEC DUO, CONTEC LC, CONTEC LCR
K030644 · DYH
Dentaurum
Dental · 266d
Cleared Nov 21, 2003
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K031842 · PDU
Intra Luminal Therapeutics, Inc.
Cardiovascular · 158d
Cleared Nov 21, 2003
ELECTRO FLO PERCUSSOR, MODEL 5000
K031876 · BYI
Med Systems
Anesthesiology · 157d
Cleared Nov 21, 2003
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
K032665 · JIX
Olympus America, Inc.
Chemistry · 85d
Cleared Nov 21, 2003
AERONEB GO NEBULIZER, MODEL AG-AG2000
K032849 · CAF
Aerogen, Inc.
Anesthesiology · 70d
Cleared Nov 21, 2003
UNIMARK HOME PREGNANCY TEST DEVICE
K032992 · LCX
Biotech Atlantic, Inc.
Chemistry · 57d