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
85537–85560 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 09, 1999
CAPNOCHECK II, MODEL 8400
K991086 · CCK
Bci Intl., Inc.
Anesthesiology · 70d
Cleared Jun 09, 1999
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
K991102 · DTL
Guidant Corp.
Cardiovascular · 69d
Cleared Jun 09, 1999
P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY
K991106 · JWH
DePuy Orthopaedics, Inc.
Orthopedic · 69d
Cleared Jun 09, 1999
DORNIER LASERTRODE FIBER
K991183 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 62d
Cleared Jun 09, 1999
CADD-TPN ADMINISTRATION SET, MODEL 21-7071
K991255 · FPA
Sims Deltec, Inc.
General Hospital · 57d
Cleared Jun 09, 1999
CADD-PRIZM HIGH VOLUME ADMINISTRATION SET WITH 1.2 U FILTER AND ADD-ON...
K991301 · FPA
Sims Deltec, Inc.
General Hospital · 54d
Cleared Jun 09, 1999
K-ASSAY RHEUMATOID FACTOR
K991409 · DHR
Kamiya Biomedical Co.
Immunology · 48d
Cleared Jun 09, 1999
3402 HANDHELD PULSE OXIMETER
K991410 · DQA
Bci Intl., Inc.
Anesthesiology · 48d
Cleared Jun 09, 1999
SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION
K991600 · JAK
Siemens Corp.
Radiology · 30d
Cleared Jun 09, 1999
EPI-FOAM SILICONE SHEETING
K991604 · MDA
Biodermis Corp.
General & Plastic Surgery · 30d
Cleared Jun 09, 1999
GE LOGIQ 500
K991611 · IYO
General Electric Co.
Radiology · 30d
Cleared Jun 09, 1999
FOUNTAIN Infusion Catheter and Occluding Guide Wire
K991619 · QEY
Merit Medical Systems, Inc.
Cardiovascular · 29d
Cleared Jun 09, 1999
MODIFICATION OF: HERMES OPERATING ROOM CONTROL CENTER
K991734 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 19d
Cleared Jun 09, 1999
IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5
K991795 · MMI
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 09, 1999
IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5
K991796 · DDR
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 09, 1999
IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5
K991797 · JHX
Diagnostic Products Corp.
Chemistry · 14d
Cleared Jun 08, 1999
SOFT-LINE IJ DOUBLE LUMEN CATHETER 11.5FR X 12CM, SOFT-LINE IJ DOUBLE LUMEN...
K983511 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 244d
Cleared Jun 08, 1999
RPM RESPIRATORY GATING SYSTEM
K983629 · LHN
Varian Medical Systems, Inc.
Radiology · 236d
Cleared Jun 08, 1999
PRODIMED MICROINJECTION PIPETTES
K983713 · MQH
Prodimed
Obstetrics & Gynecology · 230d
Cleared Jun 08, 1999
AMIGO MODEL 590000
K983987 · INI
Amigo Mobility Intl., Inc.
Physical Medicine · 211d
Cleared Jun 08, 1999
VIVOSONIC
K984562 · ITX
Sonotech, Inc.
Radiology · 167d
Cleared Jun 08, 1999
MERCATOR ATRIAL HIGH DENSITY ARRAY CATHETER
K990795 · MTD
Cardiac Pathways Corp.
Cardiovascular · 90d
Cleared Jun 08, 1999
MINIMED 508 INSULIN PUMP
K990801 · LZG
Medtronic Minimed
General Hospital · 90d
Cleared Jun 08, 1999
DOSE CALC, MODEL VS. 1.02
K990833 · IYE
Integrity Medical Software, Inc.
Radiology · 88d