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
119641–119664 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET B
K913740 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
IL TEST(TM) DAT CAL/CONTROL SET C
K913741 · DKB
Instrumentation Laboratory CO
Toxicology · 62d
Cleared Oct 21, 1991
CARDIO 500
K913754 · LLZ
Kontron Elektronik GmbH
Radiology · 61d
Cleared Oct 21, 1991
FLO-GARD(R) 6200, 6300 & 8000
K913895 · FRN
Baxter Healthcare Corp
General Hospital · 52d
Cleared Oct 21, 1991
F21(R) DENTAL CEMENT
K914073 · EMA
Voco GmbH
Dental · 40d
Cleared Oct 21, 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
K914074 · FPA
Baxter Healthcare Corp
General Hospital · 40d
Cleared Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
K914261 · JGF
Em Diagnostic Systems, Inc.
Chemistry · 28d
Cleared Oct 21, 1991
ACT-II BEHIND THE EAR HEARING AID
K914418 · ESD
Telex Communications, Inc.
Ear, Nose, Throat · 18d
Cleared Oct 21, 1991
AUDIOTONE MODEL A-95 BEHIND-THE-EAR HEARING AID
K914477 · ESD
Miracle-Ear, Inc.
Ear, Nose, Throat · 13d
Cleared Oct 18, 1991
BIOKIT RPR
K910541 · GMQ
Biokit USA, Inc.
Microbiology · 256d
Cleared Oct 18, 1991
MF-500, MODIFICATION
K911144 · QGH
Elcot, Inc.
Neurology · 235d
Cleared Oct 18, 1991
INFANT/PEDIATRIC RESUSCITATION CIRCUIT W/APL
K911465 · BZD
Vital Signs, Inc.
Anesthesiology · 198d
Cleared Oct 18, 1991
PRESSURE SORE MANAGEMENT KIT
K912116 · MCY
Medical Device Inspection Co., Inc.
General & Plastic Surgery · 157d
Cleared Oct 18, 1991
AM-PAK
K912436 · GWL
Cns, Inc.
Neurology · 137d
Cleared Oct 18, 1991
MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT
K912445 · CAZ
Mega Medical, Inc.
Anesthesiology · 137d
Cleared Oct 18, 1991
ANNULUS DISPOSABLE VALVULOTOME
K912635 · MGZ
Cardio Source
Cardiovascular · 126d
Cleared Oct 18, 1991
ANNULUS VALVULOTOME
K912636 · MGZ
Cardio Source
Cardiovascular · 126d
Cleared Oct 18, 1991
AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT
K912894 · JWH
Orthomet, Inc.
Orthopedic · 109d
Cleared Oct 18, 1991
MODEL 80 HEARING AID DISPENSING SYSTEM
K913245 · ESD
3M Company
Ear, Nose, Throat · 88d
Cleared Oct 18, 1991
HYBRID FIT TOTAL HIP SYSTEM
K913246 · JDI
Kirschner Medical Corp.
Orthopedic · 88d
Cleared Oct 18, 1991
OXYGEN MASKS 81420, 81421, 81471 & 81461
K913383 · BYG
Specialty Packaging Producs, Inc.
Anesthesiology · 81d
Cleared Oct 18, 1991
QBC E-Z PREP
K913399 · JKA
Bd Becton Dickinson Vacutainer...
Hematology · 80d
Cleared Oct 18, 1991
NASAL OXYGEN CANNULA, 81585, 81587 & 81589
K913421 · CAT
Specialty Packaging Producs, Inc.
Anesthesiology · 79d
Cleared Oct 18, 1991
WOUND CARE TRAY A
K913480 · MCY
Catalina Biomedical Corp.
General & Plastic Surgery · 73d