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
145969–145992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 25, 1985
SHAW SUN SYSTEMS 1000, 2000 & 3200
K854515 · FTC
Shaw Sun Systems
General & Plastic Surgery · 13d
Cleared Nov 25, 1985
TOTAL PROTEIN
K854553 · CEK
American Monitor Corp.
Chemistry · 12d
Cleared Nov 22, 1985
UNILOC TOTAL HIP PROSTHESIS
K851409
Serrano Intl.
Orthopedic · 227d
Cleared Nov 22, 1985
MON-A-THERM SUBCUTANEOUS TEMP. SENSOR
K853392 · FLL
Mon-A-Therm, Inc.
General Hospital · 101d
Cleared Nov 22, 1985
APR REVISION HIP PROSTHESIS, FEMORAL COMPONENT
K853524 · KMC
Intermedics Orthopedics
Orthopedic · 92d
Cleared Nov 22, 1985
KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD
K853795 · KWY
Kirschner Medical Corp.
Orthopedic · 72d
Cleared Nov 22, 1985
EXTERNAL MECHANICAL FASTENER
K854068
Wells Johnson Co.
General & Plastic Surgery · 49d
Cleared Nov 22, 1985
CALCITONIN RIA KIT
K854240 · JKR
Diagnostic Systems Laboratories, Inc.
Chemistry · 32d
Cleared Nov 22, 1985
SILICONE OIL 350 CNETISTOKE
K854273 · KRD
Pacific Medical Industries
Cardiovascular · 63d
Cleared Nov 22, 1985
GLUCOSE REAGENT SET (GOD/TRINDER)
K854335 · CGA
Sterling Diagnostics, Inc.
Chemistry · 25d
Cleared Nov 22, 1985
DELTA-LITE CASTING RESIN
K854341 · LGF
Johnson & Johnson Professionals, Inc.
Orthopedic · 25d
Cleared Nov 22, 1985
MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL
K854420 · GDM
Meadox Surgimed, Inc.
General & Plastic Surgery · 18d
Cleared Nov 22, 1985
FALKON STRETCH
K854432 · EFQ
G.B.F. Industries, Inc.
General & Plastic Surgery · 17d
Cleared Nov 22, 1985
MIDAS REX SURGICAL RUBBER DAM
K854462
Midas Rex Pneumatic Tools, Inc.
General & Plastic Surgery · 16d
Cleared Nov 21, 1985
THE NEW MCINTYRE CANNULA
K853777 · HMX
Microsurgical Technology, Inc.
Ophthalmic · 73d
Cleared Nov 21, 1985
CPAP BLOWER
K853944 · BTI
American Air & Process, Inc.
Anesthesiology · 58d
Cleared Nov 21, 1985
PLAYTEX LIGHT'N GENTLE UNSCENTED/DEODORANT/MINI TA
K854258 · HIL
Intl. Playtex, Inc.
Obstetrics & Gynecology · 30d
Cleared Nov 20, 1985
THERMO TRIM
K852637 · IRT
Suntec Health & Fitness Group, Inc.
Physical Medicine · 153d
Cleared Nov 20, 1985
ALPHA SUPER KART
K853766 · INI
Alpha Unlimited, Inc.
Physical Medicine · 72d
Cleared Nov 20, 1985
IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES
K854423 · LIB
Dynatech Laboratories, Inc.
Microbiology · 15d
Cleared Nov 20, 1985
BARD PARKER 150CC BELLOWS RESERVOIR
K854424 · GCY
Bd Becton Dickinson Vacutainer...
General & Plastic Surgery · 15d
Cleared Nov 19, 1985
GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO
K851244 · KDQ
Cook, Inc.
General Hospital · 266d
Cleared Nov 19, 1985
SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000
K851625 · DSF
Eaton Medical Group
Cardiovascular · 215d
Cleared Nov 19, 1985
SYS STIM 206 MODEL ME206
K851735 · GZJ
Mettler Electronics Corp.
Neurology · 208d