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
110233–110256 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 01, 1994
SERIES 8920 TROCAR SYSTEM
K932441 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 257d
Cleared Feb 01, 1994
GC IV CORONARY GUIDING CATHETER
K932933 · DQY
Medtronics Interventional Vascular
Cardiovascular · 230d
Cleared Feb 01, 1994
MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER
K933011 · EZN
Boston Scientific Corp
Gastroenterology & Urology · 225d
Cleared Feb 01, 1994
COMFIT
K933263 · LYY
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 210d
Cleared Feb 01, 1994
EUREKA
K933623 · EJT
J.F. Jelenko & Co., Inc.
Dental · 197d
Cleared Feb 01, 1994
PUNCH SURGICAL
K933772 · LXH
Mahe-Medizintechnik
Orthopedic · 187d
Cleared Feb 01, 1994
ULTRA SHIELD PF
K934171 · LYY
Medical Resources International, Inc.
General Hospital · 159d
Cleared Feb 01, 1994
VCI SUCTION/IRRIGATION TUBING SET
K934382 · JOL
Vital Concepts, Inc.
General Hospital · 145d
Cleared Feb 01, 1994
GSI 60 DPOAE SYSTEM
K934658 · EWO
Lucas Grason-Stadler, Inc.
Ear, Nose, Throat · 126d
Cleared Feb 01, 1994
AIR COMPRESSOR, MODEL PAC 6.7
K934815 · EIA
Defiance Electronics, Inc.
Dental · 119d
Cleared Feb 01, 1994
REFLECTIONS
K934881 · EJF
Cdb Corp.
Dental · 112d
Cleared Feb 01, 1994
AGAFAR FACE SHIELD
K935779 · LYU
Infection Control Products, Inc.
General Hospital · 60d
Cleared Jan 31, 1994
PM2002 PROLINE
K923534 · KLC
Planmeca USA, Inc.
Dental · 564d
Cleared Jan 31, 1994
HYDRO-TEMP NICU AND SKIN SURFACE TEMPERATURE SENSO
K925006 · FMT
Deroyal Industries, Inc.
General Hospital · 486d
Cleared Jan 31, 1994
TEK-LUBE
K925080 · EFB
Clinical Technology Corp.
Dental · 481d
Cleared Jan 31, 1994
A-DEC 1040 CHAIR
K925119 · KLC
A-Dec, Inc.
Dental · 479d
Cleared Jan 31, 1994
ARTHREX INSTRUMENTS ( HIP )
K926212 · HRX
Arthrex, Inc.
Orthopedic · 417d
Cleared Jan 31, 1994
ARTROMOT K2 CPM
K931555 · BXB
Ormed Mfg., Inc.
Physical Medicine · 307d
Cleared Jan 31, 1994
HF-110A
K932353 · IZL
Dynarad Corp.
Radiology · 263d
Cleared Jan 31, 1994
NEUROMUSCULAR STIMULATOR
K932611 · GZJ
Myo/Kinetic Systems, Inc.
Neurology · 248d
Cleared Jan 31, 1994
INTERSECT SYSTEMS DIRECT AMYLASE REAGENT
K932888 · JFJ
Intersect Systems, Inc.
Chemistry · 231d
Cleared Jan 31, 1994
B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES
K933062 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 214d
Cleared Jan 31, 1994
COMPUTED ORAL RADIOLOGY SYSTEM
K933455 · EAP
Schick Technologies, Inc.
Radiology · 201d
Cleared Jan 31, 1994
EPIDURAL ANESTHESIA PROCEDURE TRAY, CUSTOM
K933721 · CAZ
Neurodelivery Technology, Inc.
Anesthesiology · 182d