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
93985–94008 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 01, 1997
BENCHMARK TRANSFER TEST
K954730 · BZC
P.K. Morgan , Ltd.
Anesthesiology · 533d
Cleared Apr 01, 1997
ONCE-A-DAY BOWIE AND DICK TEST PACK.
K961156 · JOJ
Propper Mfg. Co., Inc.
General Hospital · 375d
Cleared Apr 01, 1997
UMBILICAL CLAMP AND CUTTER
K963428 · HFW
R.O.S.T. Medical Development, Inc.
Obstetrics & Gynecology · 214d
Cleared Apr 01, 1997
DIOLITE 532
K964074 · GEX
Iriderm Div.
General & Plastic Surgery · 172d
Cleared Apr 01, 1997
LINAC SCALPEL FLOORSTAND
K964517 · IYE
Surgical Navigation Technologies, Inc.
Radiology · 140d
Cleared Apr 01, 1997
FPT NEBULIZER
K970010 · CAF
Fluid Propulsion Technologies, Inc.
Anesthesiology · 89d
Cleared Apr 01, 1997
JOHN BUNN NEB-U-LITE II MEDICATION COMPRESSOR WITH DISPOSABLE NEBULIZER,...
K970035 · CAF
Graham-Field, Inc.
Anesthesiology · 88d
Cleared Apr 01, 1997
EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEM
K970290 · KTT
Ebi, L.P.
Orthopedic · 67d
Cleared Apr 01, 1997
NEO-PICC
K970434 · LJS
Klein-Baker Medical, Inc.
General Hospital · 55d
Cleared Apr 01, 1997
UPSCAN 120
K970450 · LLZ
Merlin Engineering Works, Inc.
Radiology · 54d
Cleared Apr 01, 1997
D SERIES ELECTRODE
K970603 · DSB
Cmc Sense-It, Inc.
Cardiovascular · 42d
Cleared Apr 01, 1997
REGENT BIOGEL SURGICAL GLOVE, BIOGEL M GLOVE
K970924 · KGO
Regent Medical
General Hospital · 25d
Cleared Apr 01, 1997
PROSTYLE INTRA
K970975 · EHD
Planmeca Oy
Radiology · 15d
Cleared Mar 31, 1997
PERFECT CHOICE PROPHY PASTE WITH 10% CARBAMIDE PEROXIDE
K962370 · EJR
Challenge Products, Inc.
Dental · 285d
Cleared Mar 31, 1997
ELECTRIC SURGICAL IRRIGATION SYSTEM - DUAL CONTROLLER UNIT
K963843 · EFB
Micro Motors, Inc.
Dental · 187d
Cleared Mar 31, 1997
PT-PAC PORTABLE HEATING PAD
K963887 · IRT
Anthony A. Chiurco
Physical Medicine · 186d
Cleared Mar 31, 1997
ACCESSPOINT, MED E-MAIL, DICOM READER
K963936 · LMB
Biosound, Inc.
Radiology · 181d
Cleared Mar 31, 1997
E. CAM PROFILE ATTENUATION CORRECTION
K963983 · KPS
Siemens Corp.
Radiology · 178d
Cleared Mar 31, 1997
VITROTEC TRUE LIGHT ENDOILLUMINATOR (100-S)
K964555 · MPA
Vitrotec, Inc.
Ophthalmic · 138d
Cleared Mar 31, 1997
STERI-OSS TIODIZED SCREW
K964739 · DZE
Steri-Oss, Inc.
Dental · 125d
Cleared Mar 31, 1997
INTRAVIA CONTAINER, EMPTY
K964853 · KPE
Baxter Healthcare Corp
General Hospital · 118d
Cleared Mar 31, 1997
ACRYPAK FOLDER
K965185 · KYB
Alcon Laboratories
Ophthalmic · 97d
Cleared Mar 31, 1997
AUDALLION II HEARING SYSTEM
K970215 · ESD
Resound Corp.
Ear, Nose, Throat · 69d
Cleared Mar 31, 1997
MULTI-CHANNEL COMPRESSION BTE (SD)
K970262 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 67d