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
137545–137568 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 20, 1988
ACROMED CANCELLOUS BONE SCREW
K875053 · HWC
Buckman Co., Inc.
Orthopedic · 42d
Cleared Jan 20, 1988
BIO-FEEDBACK LIMB MONITOR TYPE CODE BL-34-1
K875103 · IKE
Shield Computers , Ltd.
Physical Medicine · 41d
Cleared Jan 20, 1988
STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM
K875156 · JDQ
Richards Medical Co., Inc.
Orthopedic · 36d
Cleared Jan 19, 1988
UNI-VENT(TM) IMPACT MINUTE VOLUME VENTILATOR
K870861 · CBK
Impact Instrumentation, Inc.
Anesthesiology · 322d
Cleared Jan 19, 1988
BED ALERT
K872522 · KPN
Nite Train-R Enterprises, Inc.
Gastroenterology & Urology · 208d
Cleared Jan 19, 1988
TRANSJAW(TM)
K872815 · BXB
Vitek, Inc.
Physical Medicine · 187d
Cleared Jan 19, 1988
ATTENDS INCONTINENT BRIEF
K873036 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 168d
Cleared Jan 19, 1988
EZ BRUSH & FLOSS
K873317 · EFW
Ez Products, Ltd.
Dental · 153d
Cleared Jan 19, 1988
SCENTED OR SCENTED DEODORIZED MENSTRUAL PADS
K873457 · HIL
Procter & Gamble Mfg. Co.
Obstetrics & Gynecology · 144d
Cleared Jan 19, 1988
MEMBRANE HUMIDIFIER
K873472 · BTT
Respiratory Support Products, Inc.
Anesthesiology · 144d
Cleared Jan 19, 1988
MINI CROSSER BATTERY POWERED WHEELCHAIR
K873500 · INI
Heisteel DK Aps
Physical Medicine · 141d
Cleared Jan 19, 1988
HUCHEL BODYLINER
K873576 · IRT
Hans-Juergen Huchel
Physical Medicine · 139d
Cleared Jan 19, 1988
TRIAD NUCLEAR IMAGING SYSTEM
K873775 · KPS
Trionix Research Laboratory, Inc.
Radiology · 125d
Cleared Jan 19, 1988
SEPACELL R-500 AND SEPACELL R-500A
K873792 · CAK
Advocacy International, Ltd.
General Hospital · 124d
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