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.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
156745–156768 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 12, 1983
EXTERNAL VALVE FUNCTION BLOCK
K830914 · DRQ
Honeywell, Inc.
Cardiovascular · 141d
Cleared Aug 12, 1983
XCEL MODEL XE-1
K830992 · GZJ
Electrocaine Medical System
Neurology · 136d
Cleared Aug 12, 1983
TUFCOTE EPILATION PROBE
K831048 · KCW
Serapis Medical Electronics, Co.
General & Plastic Surgery · 134d
Cleared Aug 12, 1983
CEILING MOUNTED SUPPORT
K831086 · FQO
Amsco Co.
General & Plastic Surgery · 130d
Cleared Aug 12, 1983
EPCOM EMS-310 INTRAPARTUM MONITOR
K831113 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 12, 1983
EPCOM EMS-330 FREEDOM I TELEDOP OBSTET
K831114 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 12, 1983
EPCOM EMS-320 REMOTE MONITORSCOPE
K831115 · HGM
Epcom Medical Systems, Inc.
Obstetrics & Gynecology · 129d
Cleared Aug 12, 1983
INVAC W/VARIOUS MODELS
K831116 · GCX
Pmt
General Hospital · 129d
Cleared Aug 12, 1983
HEARCO C
K831129 · ESD
Hear Co., Inc.
Ear, Nose, Throat · 128d
Cleared Aug 12, 1983
DISPOS. ABODOMINAL RETRACTING PAD
K831130 · DWF
Product Development Corp.
Cardiovascular · 128d
Cleared Aug 12, 1983
GAUZE COMPRESS
K831281 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
BANDAGE COMPRESS
K831282 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
TRIANGLE BANDAGE STERILE
K831283 · NAD
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
GAUZE BANDAGE
K831284 · NAB
Pac-Kit Safety Equipment Co.
General & Plastic Surgery · 112d
Cleared Aug 12, 1983
TRILEX
K831315 · FPB
Tri-Med, Inc.
General Hospital · 112d
Cleared Aug 12, 1983
IVFLO-HP & IVFIL-HP FILTER
K831350 · FPB
Tri-Med, Inc.
General Hospital · 109d
Cleared Aug 12, 1983
P-S MEDICAL CSF-LUMBOPERITONEAL SHUNT
K831396 · JXG
Pudenz-Schulte Medical Research Corp.
Neurology · 105d
Cleared Aug 12, 1983
PACELINE PATIENT TRANSMITTER MODEL 324
K831443 · DXH
Pacesetter Systems
Cardiovascular · 99d
Cleared Aug 12, 1983
API UNISCEPT PLUS 140 INOCULATOR
K831462 · JTC
Analytical Products, Inc.
Microbiology · 98d
Cleared Aug 12, 1983
SC-603 TWIN VALVE
K831486 · BTM
Instrumentation Industries, Inc.
Anesthesiology · 94d
Cleared Aug 12, 1983
DISP. TRANSDUCER W/MONITORING KIT TRANS
K831506 · DRS
Sorensen Research
Cardiovascular · 93d
Cleared Aug 12, 1983
URINE TOTAL PROTEIN CONTROL
K831526 · JJW
Quantimetrix Corp.
Chemistry · 92d
Cleared Aug 12, 1983
CUI MAMMARY PROTHESIS SIZER
K831566 · MRD
Cox-Uphuff Intl.
General & Plastic Surgery · 88d
Cleared Aug 12, 1983
PHYSIOLOGICAL MONITOR #902
K831578 · DRT
Novametrix Medical Systems, Inc.
Cardiovascular · 87d