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
84481–84504 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · GGM
R&D Systems, Inc.
Hematology · 39d
Cleared Nov 12, 1999
EZFLOW MAX, MODEL 1007
K993558 · CAF
Piper Medical Products
Anesthesiology · 23d
Cleared Nov 12, 1999
IMPRESARIO
K993620 · DQK
Del Mar Medical Systems, LLC
Cardiovascular · 17d
Cleared Nov 12, 1999
FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM
K993632 · CGA
Selfcare, Inc.
Immunology · 16d
Cleared Nov 12, 1999
LEGEND CRF FLUORO AND RAD SYSTEM
K993665 · KPR
Ge Medical Systems, Inc.
Radiology · 14d
Cleared Nov 10, 1999
FS 1000 KNEE SYSTEM
K991052 · JWH
Renaissance Instruments, LLC
Orthopedic · 225d
Cleared Nov 10, 1999
MEDCOMP DUO-FLOW II CATHETER WITH LUBRICIOUS HEPARIN
K991320 · MPB
Medical Components, Inc.
Gastroenterology & Urology · 205d
Cleared Nov 10, 1999
ROADRUNNER, PEP THERAPY DEVICE
K991561 · BWF
Dhd Healthcare Corp.
Anesthesiology · 190d
Cleared Nov 10, 1999
THE TAPER-FIT TOTAL HIP SYSTEM
K992234 · JDG
Corin USA
Orthopedic · 131d
Cleared Nov 10, 1999
TERATECH, MODEL 2000 IMAGING IMAGING
K992505 · IYO
Teratech Corp.
Radiology · 106d
Cleared Nov 10, 1999
POLYGRAF ID, POLYGRAM '98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODELS...
K992713 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 90d
Cleared Nov 10, 1999
PRIMEAIRE
K992722 · CAF
Thayer Medical Corp.
Anesthesiology · 89d
Cleared Nov 10, 1999
E.CAM COMPUTER
K992731 · KPS
Siemens Medical Solutions USA, Inc.
Radiology · 89d
Cleared Nov 10, 1999
AKRON ATP9 TRACTION MACHINE
K992733 · ITH
Huntleigh Technology, Inc.
Physical Medicine · 89d
Cleared Nov 10, 1999
VACUUM ASSIST STABILIZER
K992833 · MWS
Cardio Thoracic Systems
Cardiovascular · 79d
Cleared Nov 10, 1999
LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070
K992857 · DTW
Rocky Mountain Research, Inc.
Cardiovascular · 77d
Cleared Nov 10, 1999
COMPONENTS FOR CARDIOVASCULAR PROCEDURE KIT
K992906 · DTL
Olson Medical Sales, Inc.
Cardiovascular · 72d
Cleared Nov 10, 1999
RESPIRONICS TOTAL FACE MASK
K992969 · BZD
Respironics, Inc.
Anesthesiology · 68d
Cleared Nov 10, 1999
METRX SYSTEM
K993021 · HRX
Surgical Navigation Technologies, Inc.
Orthopedic · 63d
Cleared Nov 10, 1999
MILLENNIUM INFANT VENTILATOR
K993167 · CBK
Sechrist Industries, Inc.
Anesthesiology · 49d
Cleared Nov 10, 1999
MICROMEDICS S&T PARTIAL OSSICULAR REPLACEMENT PROSTHESIS
K993234 · ETB
Micromedics, Inc.
Ear, Nose, Throat · 44d
Cleared Nov 10, 1999
AUTOJET 2 (NON-FIXED NEEDLE TYPE)
K993385 · KZH
Owen Mumford USA, Inc.
General Hospital · 33d
Cleared Nov 10, 1999
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
K993434 · DXY
Biotronik, Inc.
Cardiovascular · 29d
Cleared Nov 10, 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · LYY
Sri Johani Sdn. Bhd.
General Hospital · 28d