Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
137569–137592 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jan 19, 1988
CPE 2000 CARDIO PULMONARY ERGOMETER
K874925 · KRI
Medical Graphics Corp.
Cardiovascular · 48d
Cleared Jan 19, 1988
UNIVERSAL EXAMINATION TABLE
K874934 · KXJ
Imatron, Inc.
Radiology · 46d
Cleared Jan 19, 1988
HERCO SILICONE RESUSCITATOR OR SUN-MED RESUSCITA.
K875077 · BTM
Herco Products, Inc.
Anesthesiology · 41d
Cleared Jan 19, 1988
KODAK KODAFLEX II CASSETTE
K875083 · IXA
Eastman Kodak Company
Radiology · 41d
Cleared Jan 19, 1988
SHIMADZU CATHETERIZATION C-ARM STAND MH-50A
K875157 · JAA
Shimadzu Precision Instruments, Inc.
Radiology · 35d
Cleared Jan 19, 1988
ESOPHAGEAL OBTURATOR/TRACHEAL TUBE
K875226 · CAO
Sheridan Catheter Corp.
Anesthesiology · 28d
Cleared Jan 19, 1988
VARIVIEWER (X-RAY FILM VIEWER)
K875233 · IXC
Diversified Diagnostic Products, Inc.
Radiology · 28d
Cleared Jan 19, 1988
MON-A-THERM'S SKIN TEMPERATURE SENSOR
K875234 · FLL
Mon-A-Therm, Inc.
General Hospital · 28d
Cleared Jan 19, 1988
ISOKINETIC SYSTEM, TESTING AND EVALUATION
K875235 · IKK
Orthopedic Systems, Inc.
Physical Medicine · 28d
Cleared Jan 19, 1988
INFANT INTENSIVE CARE SYSTEM VERTICAL HEIGHT ADJUS
K875270 · FMT
Air-Shields, Inc.
General Hospital · 28d