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
165505–165528 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 13, 1981
SUN TANNING DEVICES
K803061 · LEJ
Mutzhas Corp.
Radiology · 40d
Cleared Jan 13, 1981
NARCO TELECARE TRANSDUCER DOME #700-4000
K803096 · DRS
Narco Scientific
Cardiovascular · 36d
Cleared Jan 13, 1981
CRT DISPLAY #1310B
K803123 · DXJ
Hewlett-Packard Co.
Cardiovascular · 33d
Cleared Jan 13, 1981
CONPHAR VELCRO TOUNIGUER
K803142 · GAX
Conphar, Inc.
General & Plastic Surgery · 32d
Cleared Jan 13, 1981
ADVANCEMED CCU DOCUMENTOR
K803222 · DSH
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCMED ELIMINATOR
K803223 · DRT
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCEMED HOLTER RECORDERS
K803224 · DSH
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
ADVANCEMED EXAMINER
K803225 · DSF
American Edwards Laboratories
Cardiovascular · 25d
Cleared Jan 13, 1981
4-CHANNEL ECG TELEMETRY MON. SYST. #3045
K803229 · DRG
Cambridge Instruments, Inc.
Cardiovascular · 25d
Cleared Jan 13, 1981
TYGON TUBING
K803277 · DWE
Electromedics, Inc.
Cardiovascular · 15d
Cleared Jan 13, 1981
MATTRESS, AIR FLOATATION, ALTERN. PRESS.
K803307 · FNM
Intl. Medical Equipment Corp.
General Hospital · 14d
Cleared Jan 12, 1981
UTERINE CURETTE
K802313 · HCY
Gynemetrics, Inc.
Obstetrics & Gynecology · 111d
Cleared Jan 12, 1981
UTERINE SOUND
K802315 · HHM
Gynemetrics, Inc.
Obstetrics & Gynecology · 111d
Cleared Jan 12, 1981
KEVORKIAN-YOUNGE BIOPSY PUNCH, #90-6610
K802457 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 96d
Cleared Jan 12, 1981
KEVORKIAN-YOUNGE BIOPSY CURETTE #90-6611
K802458 · HFB
J. Sklar Mfg. Co., Inc.
Obstetrics & Gynecology · 96d
Cleared Jan 12, 1981
PETAL SOFT PLASTIC APPLICATOR TAMPAX
K802760 · HEB
Tampax, Inc.
Obstetrics & Gynecology · 68d
Cleared Jan 12, 1981
INFLUENZA A & B S-ANTIGEN & CONTROLS
K802931 · GNX
Orion Diagnostica, Inc.
Microbiology · 54d
Cleared Jan 12, 1981
MEUROMETRICS MONITOR
K803233 · GWS
Dade Medical, Inc.
Neurology · 21d
Cleared Jan 12, 1981
MICROMEDIC REAGENT DISPENSER
K803252 · JTC
Micromedic Systems
Microbiology · 20d
Cleared Jan 12, 1981
MINI-TIP CULTURETTE
K803298 · JTW
Marion Laboratories, Inc.
Microbiology · 13d
Cleared Jan 09, 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
K802220 · CDD
Corning Medical & Scientific
Hematology · 119d
Cleared Jan 09, 1981
EMG-UT 30
K802390 · HCC
American Scientific Corp.
Neurology · 99d
Cleared Jan 09, 1981
EMG-UT 40
K802391 · HCC
American Scientific Corp.
Neurology · 99d
Cleared Jan 09, 1981
BLF EIKEN KIT DETER. OF B-LIPOPR. FRAC.
K802451 · JHQ
Syn-Kit, Inc.
Chemistry · 93d