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
119377–119400 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Oct 18, 1991
POLAR PUMP, MODEL 500
K913729 · ILO
Breg, Inc.
Physical Medicine · 59d
Cleared Oct 18, 1991
CORDIS PTCA GUIDING CATHETER, MODIFICATION
K913783 · DQY
Dow Corning Wright
Cardiovascular · 65d
Cleared Oct 18, 1991
HEMOCHRON(R) KACT
K913861 · JBP
International Technidyne Corp.
Hematology · 52d
Cleared Oct 18, 1991
DOX TAMPERPROOF SPECIMEN CONTAINER SYSTEM
K913967 · KDW
Doxtech, Inc.
Chemistry · 43d
Cleared Oct 18, 1991
CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH
K914007 · DQO
Cordis Corp.
Cardiovascular · 39d
Cleared Oct 18, 1991
GOLDEN THERMAL(R)
K914182 · ILO
Seabrook Medical Systems, Inc.
Physical Medicine · 30d
Cleared Oct 17, 1991
PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET
K910693 · JOL
Baxter Healthcare Corp
General Hospital · 240d
Cleared Oct 17, 1991
HOTLINE FLUID WARMER
K911383 · LGZ
Level 1 Technologies, Inc.
General Hospital · 203d
Cleared Oct 17, 1991
PEDIA PALS
K911650 · ERA
Pedia Pals, Inc.
Ear, Nose, Throat · 188d
Cleared Oct 17, 1991
SIMON NITINOL FILTER, MODIFICATION
K912144 · DTK
Nitinol Medical Technologies, Inc.
Cardiovascular · 157d
Cleared Oct 17, 1991
BI-TEMP TEMPERATURE MONITOR, MODEL TM-400D
K912280 · FLL
Respiratory Support Products, Inc.
General Hospital · 147d