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
136969–136992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1988
LYPHOCHEK SPINAL FLUID CONTROL (HUMAN)
K880494 · JJY
Bio-Rad
Chemistry · 28d
Cleared Mar 03, 1988
CEILING MOUNTED TILTING TABLE TANGENT III
K880529 · IXR
Fischer Imaging Corp.
Radiology · 23d
Cleared Mar 03, 1988
CEILING MOUNTED RADIOGRAPHIC SYSTEM TRAUMEX
K880530 · IYB
Fischer Imaging Corp.
Radiology · 23d
Cleared Mar 03, 1988
KING SYSTEMS, BREATHING BAG
K880680 · BTC
King Systems Corp.
Anesthesiology · 13d
Cleared Mar 03, 1988
SLIDE CULTURE PLATE-POTATO FLAKE AGAR
K880716 · JSJ
Remel Co.
Microbiology · 9d
Cleared Mar 03, 1988
SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR
K880717 · JSJ
Remel Co.
Microbiology · 9d
Cleared Mar 02, 1988
ULTRA-FRESH DEODORANT
K871313 · GDS
Mentor Corp.
Gastroenterology & Urology · 336d
Cleared Mar 02, 1988
RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA.
K871555 · DXK
General Electric Co.
Cardiovascular · 315d
Cleared Mar 02, 1988
CLEARFIL PHOTO POSTERIOR
K872588 · EBF
Kuraray Co.
Dental · 245d
Cleared Mar 02, 1988
BRONCHODILATOR TEE - 9056 SERIES
K873521 · CAF
Boehringer Laboratories
Anesthesiology · 183d
Cleared Mar 02, 1988
DOPPLEX ULTRASONIC DOPPLER SYSTEM
K873989 · JOP
Ultramed, Inc.
Cardiovascular · 154d
Cleared Mar 02, 1988
NON-ROTATING GOLD CYLINDER AND SCREW
K874400 · DZE
Implant Innovations International, Inc.
Dental · 126d
Cleared Mar 02, 1988
AIK-100 ANESTHESIA INDUCTION KIT/TRAY
K874674 · CAZ
Medical Repackers Co.
Anesthesiology · 110d
Cleared Mar 02, 1988
BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBE
K875119 · FCI
Advanced Diagnostic Medical Systems,...
Gastroenterology & Urology · 78d
Cleared Mar 02, 1988
MIC (SPECIFIC LINE) INSERTION KIT
K875126 · KNT
Medical Innovations Corp.
Gastroenterology & Urology · 78d
Cleared Mar 02, 1988
LAPAROFLATOR 3000, STANDARD AND ELECTRONIC
K875137 · HES
F.M. Wiest USA, Inc.
Obstetrics & Gynecology · 78d
Cleared Mar 02, 1988
PHARMASEAL STERILE UMBILICAL CORD CLAMP
K875166 · HWI
Baxter Healthcare Corp
Orthopedic · 76d
Cleared Mar 02, 1988
LUER LOCK CONNECTORS / RIDIG P.V.C.
K875188 · LFJ
Vas-Cath of Canada , Ltd.
Gastroenterology & Urology · 76d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. SUPER TAMPON
K880022 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 02, 1988
TAMPAX COMPAK, COMPACT PLASTIC APPLI. REGU. TAMPON
K880023 · HIL
Tambrands, Inc.
Obstetrics & Gynecology · 57d
Cleared Mar 02, 1988
CLOSED URINARY DRAINAGE BAG W/ANTI-REFLUX & PORT
K880034 · KNX
Lin-Mark, Inc.
Gastroenterology & Urology · 57d
Cleared Mar 02, 1988
BERGER PROSTATE CULTURE CYTOLOGY BRUSH
K880095 · FDX
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC ASPIRATION BIOPSY SYSTEM W/COLLECTION CUP
K880096 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d
Cleared Mar 02, 1988
VAN-TEC AUTO BIOPSY NEEDLE
K880098 · KNW
Van-Tec, Inc.
Gastroenterology & Urology · 50d