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
134929–134952 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 11, 1988
INDICATENS 4X4
K881708 · GZJ
Acudata Software
Neurology · 113d
Cleared Aug 11, 1988
SURGITEK CO2 DELIVERY SYSTEM
K881736 · FAP
Medical Engineering Corp.
Gastroenterology & Urology · 111d
Cleared Aug 11, 1988
MODEL 90DX MULTITEST METER
K882032 · FLB
Mesa Medical, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 11, 1988
ENTRUST(TM) MODEL 800
K882047 · FRN
Avi, Inc.
General Hospital · 87d
Cleared Aug 11, 1988
PERFUSOR M SYRINGE PUMP
K882106 · FRN
Burron Medical, Inc.
General Hospital · 85d
Cleared Aug 11, 1988
PERFUSOR SECURA SYRINGE PUMP
K882107 · FRN
Burron Medical, Inc.
General Hospital · 84d
Cleared Aug 11, 1988
CENTRIX TRI-LAMINATE POST SYSTEM
K882125 · ELR
Centrix, Inc.
Dental · 83d
Cleared Aug 11, 1988
INTERSEPT* OXYGEN GAS LINE FILTER
K882136 · KRD
Medtronic Blood Systems, Inc.
Cardiovascular · 83d
Cleared Aug 11, 1988
VTR-12
K882176 · JAA
Eigen
Radiology · 79d
Cleared Aug 11, 1988
VIEWPOINT
K882205 · LLZ
Adac Laboratories
Radiology · 77d
Cleared Aug 11, 1988
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690 · ELW
3M Company
Dental · 42d
Cleared Aug 10, 1988
LASERMATIC SURGILASER MODEL 5050
K870587 · EWG
Lasermatic OY
Ear, Nose, Throat · 547d
Cleared Aug 10, 1988
LAMINARIA CUREX
K881295 · HDY
Harold W. Berger Co.
Obstetrics & Gynecology · 135d
Cleared Aug 10, 1988
KIMGUARD (REGULAR & HEAVY DUTY) STERILE WRAP
K881471 · FRG
Kimberly-Clark Corp.
General Hospital · 125d
Cleared Aug 10, 1988
SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS.
K881899 · DHB
Diagnostic Products Corp.
Immunology · 96d
Cleared Aug 10, 1988
HUNTLEIGH DOUBLE BUBBLE AIR-O-PAD-AOP5
K882644 · FNM
Huntleigh Technology, Inc.
General Hospital · 44d
Cleared Aug 10, 1988
CENTRIX NEEDLETUBE
K882651 · EKJ
Centrix, Inc.
Dental · 44d
Cleared Aug 10, 1988
EFFNER ILLUMINATED NASAL TRACHEOSTOMA SPECULUM
K882744 · EOB
Effner, Inc.
Ear, Nose, Throat · 40d
Cleared Aug 10, 1988
C-MASK
K882882 · FXX
Promedica Products, Inc.
General Hospital · 30d
Cleared Aug 10, 1988
C-MASK(FLAT)
K882883 · FXX
Promedica Products, Inc.
General Hospital · 30d
Cleared Aug 10, 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · FMF
Medex, Inc.
General Hospital · 19d
Cleared Aug 10, 1988
CASF STERILIZATION TRAY
K883125 · FSM
Terray Manufacturing, Inc.
General & Plastic Surgery · 15d
Cleared Aug 10, 1988
CASF STERILIZATION TRAY
K883193 · FSM
Terray Manufacturing, Inc.
General & Plastic Surgery · 13d
Cleared Aug 09, 1988
NOVOSTE 4, 4.2, 5 AND 6 FRENCH CATHETERS
K875127 · DQO
Novoste Corp.
Cardiovascular · 238d