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
131161–131184 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 12, 1989
PRIMROSE FEMALE EXT. CATH OR EXT. URINARY DRAINAGE
K890072 · KNY
Medireach, Inc.
Gastroenterology & Urology · 154d
Cleared Jun 12, 1989
PARAMED MODEL 9350 BLOOD PRESSURE MONITOR (9350)
K890198 · DXN
Paramed Technology, Inc.
Cardiovascular · 145d
Cleared Jun 12, 1989
DENTAL X-RAY BITE BLOCK
K890355 · EGZ
Bite-A-Block
Dental · 139d
Cleared Jun 12, 1989
EXTENDED OBSTETRICS SOFTWARE COMPUTATION PACKAGE
K890637 · HEM
Elscint, Inc.
Obstetrics & Gynecology · 124d
Cleared Jun 12, 1989
ROTATING HEMOSTATIC VALVE
K890800 · LIT
Datascope Corp.
Cardiovascular · 116d
Cleared Jun 12, 1989
CAV 3.0C SOFTWARE PROGRAM
K890932 · BZK
Siemens Life Support Systems
Anesthesiology · 108d
Cleared Jun 12, 1989
MODIFIED PROFILE HIP ACETABULAR PROSTHESIS
K891408 · JDX
Depuy, Inc.
Orthopedic · 90d
Cleared Jun 12, 1989
MODEL 116 FETAL MONITOR
K891595 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 84d
Cleared Jun 12, 1989
MODELS 6526,6527,6528 PERCU. TRANS. ANGIO. CATH.
K891611 · LJT
Medtronic Versaflex, Inc.
General Hospital · 84d
Cleared Jun 12, 1989
DRILLING MACHINE W/HANDPIECES & INTERNAL IRRIGA.
K891612 · EFD
Implant Innovations International, Inc.
Dental · 84d
Cleared Jun 12, 1989
NEOCHROME(R) III GLUCOSE
K892002 · CGA
American Monitor Corp.
Chemistry · 76d
Cleared Jun 12, 1989
FRANZ(TM) MOVEABLE STYLET MAP CATHETER, MODIFIED
K892207 · DRF
Ep Technologies, Inc.
Cardiovascular · 70d
Cleared Jun 12, 1989
DENTAL PLASTIC BITE FORK
K892373 · EJP
Texapol Corp.
Dental · 67d
Cleared Jun 12, 1989
KENDALL CURITY ENDOTRACHEAL TUBES
K892432 · BTR
The Kendal Co.
Anesthesiology · 63d
Cleared Jun 12, 1989
KENDALL CURITY OXYGEN NASAL CANNULA
K892435 · CAT
The Kendal Co.
Anesthesiology · 63d
Cleared Jun 12, 1989
REPRO-MED NEONATE ASPIRATION SYSTEM
K892529 · BSY
Repro-Med Systems, Inc.
Anesthesiology · 62d
Cleared Jun 12, 1989
GEM II ORTHODONTIC BRACKET
K892704 · EJF
Ormco Corp.
Dental · 59d
Cleared Jun 12, 1989
ARGELITE 54B
K892811 · EJT
Argen Precious Metals, Inc.
Dental · 56d
Cleared Jun 12, 1989
OPHTHASCAN 'S' MINI-A
K893035 · IYO
Biophysic Medical, Inc.
Radiology · 49d
Cleared Jun 12, 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
K893037 · DYH
American Orthodontics
Dental · 49d
Cleared Jun 12, 1989
ARGENCO W+
K893227 · EJT
Argen Precious Metals, Inc.
Dental · 46d
Cleared Jun 12, 1989
ALPHA SHOPPER
K893428 · ITI
Alpha Unlimited, Inc.
Physical Medicine · 41d
Cleared Jun 12, 1989
ALPHA CONDOR
K893429 · INI
Alpha Unlimited, Inc.
Physical Medicine · 41d
Cleared Jun 12, 1989
HANDI-LIFT/VICTORY WHEELCHAIR LIFT
K893490 · ING
The Cheney Co.
Physical Medicine · 39d