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
119905–119928 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 1991
STRETCH GAUZE BANDAGE
K912954 · NAB
Cal West Trading Co.
General & Plastic Surgery · 70d
Cleared Sep 10, 1991
EYE PAD
K912955 · EFQ
Cal West Trading Co.
General & Plastic Surgery · 70d
Cleared Sep 10, 1991
STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEM
K913488 · GEX
Sunrise Technologies, Inc.
General & Plastic Surgery · 35d
Cleared Sep 10, 1991
AIA-PACK FT4
K913493 · CEC
Tosoh Corp.
Chemistry · 35d
Cleared Sep 10, 1991
ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE
K913722 · KLN
Roche Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Sep 10, 1991
IL TEST(TM) DAT CALIBRATOR A( -)
K913739 · DKB
Instrumentation Laboratory CO
Toxicology · 21d
Cleared Sep 09, 1991
VMX MOBILE X-RAY SYSTEM
K910902 · IZL
GE Medical Systems
Radiology · 188d
Cleared Sep 09, 1991
IONOS(R) OSSICLE 5MM & 7MM
K911583 · ETA
Ionos GmbH & Co. KG
Ear, Nose, Throat · 154d
Cleared Sep 09, 1991
ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI
K912554 · KRH
Baxter Healthcare Corp
Cardiovascular · 90d
Cleared Sep 09, 1991
DAVIS AND GECK LAPRO-LOOP LIGATURE CARRIER
K912556 · GCJ
Davis & Geck, Inc.
General & Plastic Surgery · 90d
Cleared Sep 06, 1991
AUTOVAC (R) AUTOTRANSFUSION SYSTEM, 7900 MODIFIED
K904164 · CAC
Boehringer Laboratories
Anesthesiology · 360d
Cleared Sep 06, 1991
INFUSA T SYRINGE INFUSION PUMP
K904923 · FRN
Ferguson Medical
General Hospital · 310d
Cleared Sep 06, 1991
ACCUCORE TELEMETRY, MODIFICATION
K905506 · DSI
S & W Medico Teknik
Cardiovascular · 281d
Cleared Sep 06, 1991
WINGED ADMININ. SET W/NON-CORING NEEDLE
K910159 · FPA
Dmd Products
General Hospital · 234d
Cleared Sep 06, 1991
MDT/CASTLE 10/90 LOAD STATION
K910649 · FLF
Mdt Biologic Co.
General Hospital · 204d
Cleared Sep 06, 1991
MEDIZIV INFUSION SET
K911128 · FPA
Medicia Medical Products
General Hospital · 176d
Cleared Sep 06, 1991
PULPDENT ENAMEL BONDING AGENT
K911282 · KLE
Pulpdent Corp.
Dental · 171d
Cleared Sep 06, 1991
TSRH OPEN HEAD BONE SCREW
K911319 · KWP
Danek Medical, Inc.
Orthopedic · 164d
Cleared Sep 06, 1991
2ND SKIN MOIST BURN PADS WITH ALOE
K911550 · MGQ
Spenco Medical Corp.
General & Plastic Surgery · 151d
Cleared Sep 06, 1991
SHOWER MINI RD-7 SANITARY WASHER
K911551 · ILJ
Aiex USA , Ltd.
Physical Medicine · 151d
Cleared Sep 06, 1991
ACS RX SUPPORT CATHETER
K911957 · DQO
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 127d
Cleared Sep 06, 1991
SCHNEIDER MAGNUM PERIPHERAL RECANAL GUIDEWIRE
K912156 · DQX
Schneider Intl., Ltd.
Cardiovascular · 115d
Cleared Sep 06, 1991
HYPOALLERGENIC SURGICAL LATEX GLOVES
K912157 · KGO
Medigloves , Ltd.
General Hospital · 113d
Cleared Sep 06, 1991
ACQUPRO
K912176 · KPS
Trionix Research Laboratory, Inc.
Radiology · 113d