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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
133129–133152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 30, 1988
ALPHACALF SERUM
K884654 · KIT
Hyclone Laboratories, Inc.
Pathology · 23d
Cleared Nov 30, 1988
ZIMMER BEADED THREADED ACETABULAR CUP
K884658 · KWY
Zimmer, Inc.
Orthopedic · 23d
Cleared Nov 30, 1988
MQL 20 ND:YAG OPHTHALMIC LASER
K884694 · LQJ
California Laboratories, Inc.
Ophthalmic · 21d
Cleared Nov 30, 1988
SHOWER CHAIR
K884760 · INM
Linido, Inc.
Physical Medicine · 16d
Cleared Nov 30, 1988
RANEY CLIP
K884783 · FZQ
Alto Development Corp.
General & Plastic Surgery · 15d
Cleared Nov 29, 1988
ULTRAMARK 4+ ULTRASOUND W/3.5 MHZ 40R CONVEX ARRAY
K881140 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 257d
Cleared Nov 29, 1988
TRITON MODEL 100 PULSED DOPPLER BLOOD FLOWMETER
K881303 · DPT
Triton Technology, Inc.
Cardiovascular · 246d
Cleared Nov 29, 1988
GLASS IONOMER BASE
K882751 · EJK
Dentsply Intl.
Dental · 147d
Cleared Nov 29, 1988
MODEL 500V VASCULAR SPECTRUM ANALYZER
K882755 · IYN
Multigon Industries, Inc.
Radiology · 147d
Cleared Nov 29, 1988
TECHNICON ASSIST POTASSIUM
K883585 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
TECHNICON RA-100 SYSTEM POTASSIUM
K883586 · CEJ
Technicon Instruments Corp.
Chemistry · 98d
Cleared Nov 29, 1988
ZINC OXIDE EUGENOL TEMPORARY CEMENT
K883698 · EMA
E&D Dental Manufacturing Co.
Dental · 91d
Cleared Nov 29, 1988
TDX BENZODIAZEPINES SERUM
K883730 · JXM
Abbott Laboratories
Toxicology · 90d
Cleared Nov 29, 1988
HOME CLINIC PREGNANCY TEST
K883826 · LCX
Vanguard Biomedical Corp.
Chemistry · 81d