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
136969–136992 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 19, 1988
ROTATING HEMOSTATIC VALVE
K873971 · DTL
Target Therapeutics
Cardiovascular · 112d
Cleared Jan 19, 1988
FLUORO COVER
K873985 · JAA
Condor Medical
Radiology · 111d
Cleared Jan 19, 1988
MINIOX IV PORTABLE PULSE OXIMETER
K874132 · DQA
Catalyst Research Corp.
Anesthesiology · 98d
Cleared Jan 19, 1988
CONDOM (PROPHYLACTIC)
K874135 · HIS
Pactec, Inc.
Obstetrics & Gynecology · 98d
Cleared Jan 19, 1988
COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
K874188 · GKM
Coulter Electronics, Inc.
Hematology · 97d
Cleared Jan 19, 1988
OPTEC SUPPLEMENTARY KIT
K874275 · EBF
Pentron Corp.
Dental · 91d
Cleared Jan 19, 1988
SOLCO SILICONE RESUSCITATOR
K874321 · BTM
Kahn-Tact U.S.A., Inc.
Anesthesiology · 90d
Cleared Jan 19, 1988
CONCHA, CAVUM, CANAL, CONCHA-P HEARING AID
K874369 · ESD
Altamonte Hearing Clinic
Ear, Nose, Throat · 85d
Cleared Jan 19, 1988
THE WOOG ORATEST
K874374 · EAZ
Woog Intl.
Dental · 85d
Cleared Jan 19, 1988
AUDIOTONE MODEL A-90, BEHIND-THE-EAR HEARING AID
K874384 · ESD
Audiotone, Inc.
Ear, Nose, Throat · 85d
Cleared Jan 19, 1988
BARD BIOPOTENTIAL AMPLIFIER
K874441 · DRR
C.R. Bard, Inc.
Cardiovascular · 83d
Cleared Jan 19, 1988
H-H EXTERNAL VENTRICULAR DRAINAGE COLLECTION BAG
K874508 · JXG
Holter-Hausner Intl.
Neurology · 78d
Cleared Jan 19, 1988
COEUR CONTROL SYRINGE
K874579 · FMF
Coeur Laboratories, Inc.
General Hospital · 74d
Cleared Jan 19, 1988
IVAC(R) DUAL RATE ADAPTER - MODEL 70090
K874581 · FPA
Y
General Hospital · 71d
Cleared Jan 19, 1988
THERMOVENT 600, 1200, T, 02
K874597 · BYD
Portex, Inc.
Anesthesiology · 71d
Cleared Jan 19, 1988
BAXTER ACCUPORT(TM) CENTRAL VENOUS CATHETER
K874618 · DQR
Bentley Laboratories, Inc.
Cardiovascular · 71d
Cleared Jan 19, 1988
CADD-PLUS(TM) MODEL 5400 AMBULATORY INFUSION PUMP
K874649 · FRN
Pharmacia Deltec, Inc.
General Hospital · 67d
Cleared Jan 19, 1988
OTICON HEARING AID MODEL I52
K874651 · ESD
Oticon Corp.
Ear, Nose, Throat · 67d
Cleared Jan 19, 1988
AUTOMATIC VENTILATOR AV2000
K874656 · BTL
Life Support Products, Inc.
Anesthesiology · 61d
Cleared Jan 19, 1988
PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390
K874743 · DTB
Pace Medical
Cardiovascular · 62d
Cleared Jan 19, 1988
MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
K874792 · DTB
Medtronic Vascular
Cardiovascular · 60d
Cleared Jan 19, 1988
MODEL EEG 4400 WITH OPTIONAL ACCESSORIES
K874796 · GWQ
Nihon Kohden America, Inc.
Neurology · 75d
Cleared Jan 19, 1988
ARGYLE CARDIOPLEGIA CANNULA
K874834 · DWF
Sherwood Medical Co.
Cardiovascular · 56d
Cleared Jan 19, 1988
CAP-35 AND CAP35 F
K874924 · DTP
Gish Biomedical, Inc.
Cardiovascular · 48d