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
137353–137376 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 04, 1988
COHERENT XA-30/SP CO2 SURGICAL LASER
K874648 · GEX
Coherent Medical Group
General & Plastic Surgery · 83d
Cleared Feb 04, 1988
10CC SYRINGE CONTROL RING SET
K874747 · FMF
Procedure Products, Inc.
General Hospital · 78d
Cleared Feb 04, 1988
EXTRAVAKIT
K874807 · FMF
Cancer Technologies, Inc.
General Hospital · 76d
Cleared Feb 04, 1988
ORTHOMET ORTHOPEDIC STAPLES
K874914 · JDR
Orthomet, Inc.
Orthopedic · 63d
Cleared Feb 04, 1988
V-TREND RPRL CARD TEST
K875180 · GMP
Texas Immunology, Inc.
Microbiology · 49d
Cleared Feb 04, 1988
MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST
K880157 · GON
Syva Co.
Microbiology · 22d
Cleared Feb 04, 1988
EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES
K880205 · HRX
Baxter Healthcare Corp
Orthopedic · 16d
Cleared Feb 04, 1988
BREEZY WHEELCHAIR
K880280 · IOR
Motion Designs, Inc.
Physical Medicine · 13d
Cleared Feb 03, 1988
NUTRITION DELIVERY SETS FOR VM 05 AMBULA. PUMP
K871848 · KNT
Panamedix, Inc.
Gastroenterology & Urology · 267d
Cleared Feb 03, 1988
ELECTRODE TIP CLEANER
K874775 · GEI
C.R. Bard, Inc.
General & Plastic Surgery · 77d
Cleared Feb 03, 1988
ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS
K874915 · KWL
Orthomet, Inc.
Orthopedic · 62d
Cleared Feb 03, 1988
SUTTER PHALANGEAL CAP
K875249 · KWD
Sutter Biomedical, Inc.
Orthopedic · 43d
Cleared Feb 03, 1988
ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH
K875252 · LDJ
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 43d
Cleared Feb 03, 1988
BIOTROL CALIBRANT LEVEL 2
K875304 · JIX
Biotrol, USA, Inc.
Chemistry · 36d
Cleared Feb 03, 1988
ZENITH TRAVELER CHIROPRACTIC TABLE
K880222 · INW
Williams Manufacturing Co.
Physical Medicine · 14d
Cleared Feb 03, 1988
RESUBMITTED EXCALIBUR
K880271 · ISD
Quinton, Inc.
Physical Medicine · 13d
Cleared Feb 02, 1988
PIE MEDICAL SCANNER 1000
K870058 · KNG
Pie Data Medical BV
Obstetrics & Gynecology · 391d
Cleared Feb 02, 1988
ULTRASOUND LINEAR/SECTOR SCANNER 1100
K870653 · KNG
Pie Data Medical BV
Obstetrics & Gynecology · 350d
Cleared Feb 02, 1988
GLUCOSCOT II BLOOD GLUCOSE TEST SYSTEM
K870708 · LFR
Kyoto Daiichi Kagaku Co., Ltd.
Chemistry · 347d
Cleared Feb 02, 1988
MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
K870841 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 341d
Cleared Feb 02, 1988
MODEL 20-C, RL-20A/U, OB-10A/U
K872709 · HHR
Directed Energy, Inc.
Obstetrics & Gynecology · 210d
Cleared Feb 02, 1988
OVEIA (TM) DUAL ANALYTE
K872843 · JLP
Boots-Celltech Diagnostics, Inc.
Chemistry · 197d
Cleared Feb 02, 1988
OHMEDA 4700 OXICAP MONITOR
K873199 · DQA
Ohmeda Medical
Anesthesiology · 173d
Cleared Feb 02, 1988
SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE
K873892 · LNK
Laserguide
Gastroenterology & Urology · 132d