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
112153–112176 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 27, 1993
TRACHEOSTOMY KIT
K925288 · JOH
Ajs Medical Co., Inc.
Anesthesiology · 310d
Cleared Aug 27, 1993
PROCEDURE KIT
K926269 · LRO
General Medical Co.
General & Plastic Surgery · 252d
Cleared Aug 27, 1993
MEDCOMP(R) CONTINUOUS ANESTHESIA TRAY
K930539 · BSO
Medical Components, Inc.
Anesthesiology · 206d
Cleared Aug 27, 1993
PERCUTANEOUS TRACHEOSTOMY TUBE KIT
K931611 · JOH
Crandall Medical Devices
Anesthesiology · 148d
Cleared Aug 27, 1993
DRESSING CHANGE TRAY-MODIFIED
K931932 · MCY
Medsurg Industries, Inc.
General & Plastic Surgery · 130d
Cleared Aug 27, 1993
CARDIAC CATH OR ANGIOGRAPHIC TRAYS
K932218 · DQO
Associated Medical Products Co.
Cardiovascular · 112d
Cleared Aug 27, 1993
DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA
K932249 · CAZ
Bd Becton Dickinson Vacutainer...
Anesthesiology · 109d
Cleared Aug 26, 1993
PENCIL POINT SPINAL NEEDLE
K921683 · BSP
Hart Enterprises, Inc.
Anesthesiology · 505d
Cleared Aug 26, 1993
AEROSOL CHARGING ADAPTOR (FOR USE W/MININEB ONLY)
K924667 · CAF
Vortran Medical Technology 1, Inc.
Anesthesiology · 344d
Cleared Aug 26, 1993
CONDUCT ALOE GEL, #UP239-8FL. OZ/#UP245 G-1 GALLON
K925466 · GYB
Uni-Patch, Inc.
Neurology · 301d
Cleared Aug 26, 1993
RES Q AIR SYSTEM MODEL HT-1000
K926161 · BTT
C.F. Electronics, Inc.
Anesthesiology · 261d
Cleared Aug 26, 1993
PSORALITE
K930856 · FTC
Daavlin Co.
General & Plastic Surgery · 189d
Cleared Aug 26, 1993
PRO-FLO SYSTEM
K931896 · FCE
Lafayette Pharmacal, Inc.
Radiology · 133d
Cleared Aug 26, 1993
AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS
K932292 · LNH
Medrad, Inc.
Radiology · 108d
Cleared Aug 26, 1993
ABUSCREEN ONLINE LOW-CUTOFF CONTROLS
K932549 · DIF
Roche Diagnostic Systems, Inc.
Toxicology · 92d
Cleared Aug 26, 1993
CORDIS CATHETER SHEATH INTRODUCER
K932733 · DYB
Cordis Corp.
Cardiovascular · 80d
Cleared Aug 26, 1993
STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNO
K933426 · CDX
Baxter Diagnostics, Inc.
Chemistry · 44d
Cleared Aug 25, 1993
PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON
K911000 · DSP
Datascope Corp.
Cardiovascular · 901d
Cleared Aug 25, 1993
VASCO TIP/VASCOFLANGE
K913831 · DTB
Vascor Medical Corp.
Cardiovascular · 730d
Cleared Aug 25, 1993
DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL
K914802 · DSP
Datascope Corp.
Cardiovascular · 671d
Cleared Aug 25, 1993
TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT
K924050 · KWL
Orthomet, Inc.
Orthopedic · 385d
Cleared Aug 25, 1993
ANGEMED 5000 LEAD ADAPTER
K924390 · LDF
Angemed, Inc.
Cardiovascular · 359d
Cleared Aug 25, 1993
DATASCOPE MULTINEX II
K926451 · CBQ
Datascope Corp.
Anesthesiology · 244d
Cleared Aug 25, 1993
FEMORAL INTRAMEDULLARY RODS
K926465 · JDS
Applied Osteo Systems, Inc.
Orthopedic · 244d