FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
133705–133728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 01, 1988
ACUSON L538 TRANSDUCER
K883752 · IYO
Acuson Corp.
Radiology · 90d
Cleared Dec 01, 1988
EXCEL INFLATE-AID
K883769 · DXT
Medical Profiles, Inc.
Cardiovascular · 86d
Cleared Dec 01, 1988
TENDERFOOT
K883968 · FMK
International Technidyne Corp.
Hematology · 72d
Cleared Dec 01, 1988
INTERLOCKING INTRAMEDULLARY NAILS
K884610 · HSB
Depuy, Inc.
Orthopedic · 27d
Cleared Dec 01, 1988
SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
K884623 · GIO
Safe-Tec Clinical Products, Inc.
Hematology · 27d
Cleared Nov 30, 1988
ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION
K873826 · KWQ
Acromed Corp.
Orthopedic · 434d
Cleared Nov 30, 1988
CONVA-LIFT
K882406 · BXB
Numerical Concepts, Inc.
Physical Medicine · 173d
Cleared Nov 30, 1988
SUBOCCIPITAL ICE PILLOW
K882413 · IME
Ferguson Medical
Physical Medicine · 170d
Cleared Nov 30, 1988
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER
K883177 · GKZ
Texas Intl. Laboratories, Inc.
Hematology · 126d
Cleared Nov 30, 1988
DAD 16S, DATA ACQUISTION DEVICE 16 CH. SERIES
K883461 · GYE
Biohm, Inc.
Neurology · 110d
Cleared Nov 30, 1988
GE MR MAX SYSTEM
K883547 · LNH
General Electric Co.
Radiology · 103d
Cleared Nov 30, 1988
FLO-RESTER
K883696 · DXC
Bio-Vascular, Inc.
Cardiovascular · 92d
Cleared Nov 30, 1988
IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES
K883745 · CGJ
Diagnostic Products Corp.
Chemistry · 90d
Cleared Nov 30, 1988
RESUBMITTED EMA DENTIN CEMENT
K883770 · EMA
G-C Intl. Corp.
Dental · 85d
Cleared Nov 30, 1988
XTREL, MODEL NUMBER 3425
K883780 · GZB
Medtronic Vascular
Neurology · 85d
Cleared Nov 30, 1988
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
K883836 · GGK
Coulter Immunology
Hematology · 79d
Cleared Nov 30, 1988
PROFORMA HIP SYSTEM
K883941 · JDI
Orthomet, Inc.
Orthopedic · 72d
Cleared Nov 30, 1988
AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER
K883964 · CAF
Baxter Healthcare Corp
Anesthesiology · 71d
Cleared Nov 30, 1988
SONY CINE VIDEO SYSTEM SME-3300
K884008 · IZI
Sony Medical Electronics Co.
Radiology · 70d
Cleared Nov 30, 1988
MODIFIED IMPLANT FOR XOMED AUDIANT BONE CONDUCTOR
K884056 · LXB
Xomed, Inc.
Ear, Nose, Throat · 65d
Cleared Nov 30, 1988
EDWARDS ARTHROSCOPIC LEG HOLDER
K884302 · HRX
Baxter Healthcare Corp
Orthopedic · 48d
Cleared Nov 30, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECT KIT/MODIFIED
K884517 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 34d
Cleared Nov 30, 1988
SHOULDER TRANSMIT AND RECEIVE COILS
K884603 · LNH
Diasonics, Inc.
Radiology · 27d
Cleared Nov 30, 1988
MT/S CARLSON SPINE COIL, PART # 100-50082500-01
K884604 · LNH
Diasonics, Inc.
Radiology · 27d