FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
134905–134928 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1988
KENDALL CURITY & KENGUARD RED RUBBER URETHRAL CATH
K881667 · GBM
The Kendal Co.
Gastroenterology & Urology · 116d
Cleared Aug 12, 1988
GENESIS II 7.5MHZ ULTRASOUND TRANSDUCER
K881723 · JOP
Biosound, Inc.
Cardiovascular · 113d
Cleared Aug 12, 1988
PROVIDER ONE INFUSION SYSTEM
K882102 · FRN
Pancretec, Inc.
General Hospital · 85d
Cleared Aug 12, 1988
EXTENDED SHELF LIFE FOR INTERSEPT* ARTERIAL 20/40
K882137 · DTM
Medtronic Blood Systems, Inc.
Cardiovascular · 84d
Cleared Aug 12, 1988
MODIFIED TORAY FILTRYZER DIALYZERS
K882158 · FJI
Toray Industries (America), Inc.
Gastroenterology & Urology · 81d
Cleared Aug 12, 1988
MINIMON 7131B PATIENT MONITOR
K882197 · DPS
Kontron Instruments, Inc.
Cardiovascular · 79d
Cleared Aug 12, 1988
OVER THE NEEDLE CATHETER, ARTERIAL CATHETER NEEDLE
K882221 · DYB
Argon Medical Corp.
Cardiovascular · 78d
Cleared Aug 12, 1988
TRIAD ORTHODONTIC GEL
K882482 · EBI
Dentsply Intl.
Dental · 57d
Cleared Aug 12, 1988
ASTRA DENTAL IMPLANT SYSTEM
K882578 · DZE
Astra Meditec AB
Dental · 51d
Cleared Aug 12, 1988
REBUILDING STERILIZERS
K882713 · FLE
Mdt Corp., Inc.
General Hospital · 42d
Cleared Aug 12, 1988
PROFESSIONAL MODEL 7525 DELIVERY SYSTEM
K882759 · EFS
Viadent
Dental · 38d
Cleared Aug 12, 1988
CILCO VILLASENOR PACHYMETER
K882805 · IYO
Coopervision-Cilco
Radiology · 36d
Cleared Aug 12, 1988
EASY-OP, PORTABLE DENTAL CART
K882810 · EIA
Wy'East Medical Corp.
Dental · 36d
Cleared Aug 12, 1988
DENTAL FLOSS PICK
K882828 · JES
Bik Pik
Dental · 35d
Cleared Aug 12, 1988
FORTIFY
K882915 · EBF
Bisco, Inc.
Dental · 31d
Cleared Aug 12, 1988
IDS RAPID ANA SYSTEM
K882960 · JSP
Innovative Diagnostic Systems, Inc.
Microbiology · 29d
Cleared Aug 12, 1988
PALLIAG NF III
K883036 · EJT
Degussa Dental, Inc.
Dental · 24d
Cleared Aug 11, 1988
AMBUL. PH & MOTILITY RECORDER FOR MEASURE OF PARA.
K880581 · FFX
Synectics-Dantec
Gastroenterology & Urology · 183d
Cleared Aug 11, 1988
MIC NEEDLE JEJUNOSTOMY TUBE KIT
K880767 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 167d
Cleared Aug 11, 1988
DPS-33,000 WITH CENTOR OPTION
K881017 · LLZ
Adac Laboratories
Radiology · 154d
Cleared Aug 11, 1988
FIRST AMERICAN, RADIONIC, JKR, MODEL AC
K881480 · ESD
Jkr Laboratories, Inc.
Ear, Nose, Throat · 128d
Cleared Aug 11, 1988
PLEURAL BIOPSY PUNCH NEEDLE
K881624 · GDM
E.G. Dick & Assoc.
General & Plastic Surgery · 121d
Cleared Aug 11, 1988
OMNITRON REMOTE CONTROLLED RADIONUCLIDE APPLICATOR
K881665 · JAQ
Omnitron Intl., Inc.
Radiology · 115d
Cleared Aug 11, 1988
SELF ADHESIVE URINARY EXTERNAL CATH. W/REMOVE. TIP
K881678 · KNX
Hollister, Inc.
Gastroenterology & Urology · 114d