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
132793–132816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 05, 1989
MODEL 463 ELECTROCARDIORECORDER RECORDER
K884330 · DSH
Del Mar Avionics
Cardiovascular · 83d
Cleared Jan 05, 1989
MICRO-GUIDE SYSTEM
K884337 · DRA
Catheter Research C/O Burditt, Bowles...
Cardiovascular · 83d
Cleared Jan 05, 1989
ADMINISTRATION/MANOMETER SET W/3 WAY STOPCOCK
K884386 · KRK
Ethitek Pharmaceuticals Co.
Cardiovascular · 79d
Cleared Jan 05, 1989
LIVING TECHNOLOGY LASER CONTACT TIPS
K884682 · GEX
Living Technology, Inc.
General & Plastic Surgery · 58d
Cleared Jan 05, 1989
MODEL 200A ELECTRONIC FORCE-SENSING PROBE
K884813 · EIL
Vine Valley Research
Dental · 49d
Cleared Jan 05, 1989
DISPOSABLE DOME STOCK #D-300
K884919 · DRS
Advanced Medical, Inc.
Cardiovascular · 38d
Cleared Jan 04, 1989
PULMO-PATTY
K882604 · BYI
Tower Stopper, Inc.
Anesthesiology · 194d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS ANTIGEN ELISA TEST
K883935 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST
K883940 · LIQ
Ortho Diagnostic Systems, Inc.
Microbiology · 107d
Cleared Jan 04, 1989
PERFECT CHOICE
K884245 · EJK
Challenge Products, Inc.
Dental · 85d
Cleared Jan 04, 1989
PALGAFLEX AND PALGAFLEX-QUICK
K884381 · ELW
Espe GmbH (Us)
Dental · 78d
Cleared Jan 04, 1989
VOYAGER/X
K884754 · NFB
Smith-Perry Corp.
Anesthesiology · 51d
Cleared Jan 04, 1989
BERICHROM(R) PLASMINOGEN
K884766 · DDX
Behring Diagnostics, Inc.
Immunology · 51d
Cleared Jan 04, 1989
ONCOPROBE SYSTEM
K884770 · IZD
Care Wise Medical Products Corp.
Radiology · 51d
Cleared Jan 04, 1989
TWIXEL(TM)
K885056 · JES
Fouts Development, Inc.
Dental · 28d
Cleared Jan 04, 1989
IGE FASTSCREEN S6 (F1, F2, F4, F13, F14)
K885065 · DHB
3M Company
Immunology · 29d
Cleared Jan 04, 1989
AFFINITY(TM) FERRITIN IMMUNIT(TM)
K885074 · DBF
Bd Becton Dickinson Vacutainer...
Immunology · 27d
Cleared Jan 03, 1989
-AMYLASE EPS
K882225 · CIJ
Boehringer Mannheim Corp.
Chemistry · 222d
Cleared Jan 03, 1989
AUTO IMPEDANCE METER AE105 & AE106 W/AUDIOMETER
K883728 · ETY
American Electromedics Corp.
Ear, Nose, Throat · 125d
Cleared Jan 03, 1989
MODIFIED TSH IRMA KIT
K883742 · JLW
Pacific Biotech, Inc.
Chemistry · 124d
Cleared Jan 03, 1989
AUTOMATED EIA READER MODEL EL311
K884124 · JJQ
Bio-Tek Instruments, Inc.
Chemistry · 95d
Cleared Jan 03, 1989
HEARING AID, UNITRON BTE MODEL UM60-AGC0
K884288 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 83d
Cleared Jan 03, 1989
UNIREST COMPOSITE RESTORATIVE, SELF CURED
K884350 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 81d
Cleared Jan 03, 1989
PREMET, METAL PRIMER
K884391 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 77d