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
119545–119568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 07, 1991
RAHD 3100
K903313 · KPQ
Esm , Ltd.
Radiology · 440d
Cleared Oct 07, 1991
DISCOGRAPHY KIT
K910503 · IZG
B. Braun of America, Inc.
Radiology · 244d
Cleared Oct 07, 1991
7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1)
K911044 · ITX
Pie Medical Equipment B.V.
Radiology · 213d
Cleared Oct 07, 1991
AMIZYME EPSTEIN-BARR VIRUS (EBV) IGM ANTIBODY TEST
K911362 · LJN
Amico Laboratories, Inc.
Microbiology · 193d
Cleared Oct 07, 1991
RHINO-GUARD
K911785 · CAF
Micromedics, Inc.
Anesthesiology · 168d
Cleared Oct 07, 1991
VIBRATOUCH II CORDLESS WAND MASSAGER
K912383 · ISA
Conair Corp.
Physical Medicine · 136d
Cleared Oct 07, 1991
AFFINITY FREE T4 TEST SYSTEM
K912698 · CEC
Bd Becton Dickinson Vacutainer...
Chemistry · 111d
Cleared Oct 07, 1991
RIBBOND(TM)
K913040 · EBI
Ribbond, Inc.
Dental · 90d
Cleared Oct 07, 1991
MS-III MINISTIM
K913184 · BXN
Life-Tech Intl., Inc.
Anesthesiology · 81d
Cleared Oct 07, 1991
FREEDOM WHEELS AZ 100
K913901 · ITI
Arizona Freedom Wheels, Inc.
Physical Medicine · 38d
Cleared Oct 07, 1991
AUGUSTINE GUIDE KIT WITH GAUZE SPONGE
K914168 · CCW
Augustine Medical, Inc.
Anesthesiology · 20d
Cleared Oct 07, 1991
AMBU SILICONE RESUSCITATOR INFANT/CHILD
K914187 · BTM
Ambu, Inc.
Anesthesiology · 19d
Cleared Oct 05, 1991
COX DISPOSABLE BIOPSY FORCEP
K913883 · FCL
Cox Medical Ent., Inc.
Gastroenterology & Urology · 37d
Cleared Oct 04, 1991
TSIR ANGLED ABUTMENTS
K910585 · DZE
Core-Vent Corp.
Dental · 235d
Cleared Oct 04, 1991
SIMMONS PLATING SYSTEM
K910681 · KWQ
Smith & Nephew Richards, Inc.
Orthopedic · 231d
Cleared Oct 04, 1991
AMSET(TM) BONE SCREW
K911768 · HWC
Advanced Med/Surg, Inc.
Orthopedic · 168d
Cleared Oct 04, 1991
URI-THREE(TM), MODIFICATION
K911846 · JXA
Culture Kits, Inc.
Microbiology · 169d
Cleared Oct 04, 1991
MEDI GUARD DENTAL BIB
K911944 · KKX
Sancella, Inc.
General Hospital · 156d
Cleared Oct 04, 1991
PYLORITRAK
K912215 · LYR
Bainbridge Laboratories, Inc.
Microbiology · 137d
Cleared Oct 04, 1991
HA MCCUTCHEN SLT HIP SYSTEM
K912452 · MEH
Dow Corning Wright
Orthopedic · 123d
Cleared Oct 04, 1991
MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO
K912457 · LYU
Medical Armor Corp.
General Hospital · 123d
Cleared Oct 04, 1991
LAPAROSCOPIC ELECTROSURGICAL CANNULA W/RETRACTABLE
K912637 · GEI
Dexide, Inc.
General & Plastic Surgery · 112d
Cleared Oct 04, 1991
CONFORMING BANDAGE
K912692 · NAB
Ulti-Med Intl., Inc.
General & Plastic Surgery · 108d
Cleared Oct 04, 1991
POST OPERATIVE SPONGE
K912693 · NAB
Ulti-Med Intl., Inc.
General & Plastic Surgery · 108d