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
171433–171456 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 27, 1978
ORTHO*T-3 RIA (PEG) KIT
K781481 · CDP
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-3 UPTAKE KIT
K781482 · KHQ
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
ORTHO*T-4 RIA (PEG) KIT
K781483 · CDX
Ortho Diagnostics, Inc.
Chemistry · 30d
Cleared Sep 27, 1978
STERI-VAC POWER UNITS
K781486 · EHZ
Cpac, Inc.
Dental · 30d
Cleared Sep 27, 1978
MVS-MODEL SEU-6, DEU-6
K781488 · EHZ
Dentsply Intl.
Dental · 30d
Cleared Sep 27, 1978
PRO-MOLD, CUSTOM EAR
K781491 · EWD
Mcghan Medical Corp.
Ear, Nose, Throat · 30d
Cleared Sep 27, 1978
TECHNICON STAT/LYTE ISE ELECTROLYTE
K781503 · JJC
Technicon Instruments Corp.
Chemistry · 28d
Cleared Sep 27, 1978
TEST SYSTEM TISSUE CELL CULTURE SLIDE
K781516 · KIY
Zeus Scientific, Inc.
Pathology · 27d
Cleared Sep 27, 1978
COULTER ELECTROLYTE ANALYZER SYSTEM
K781528 · JJE
Coulter Electronics, Inc.
Chemistry · 22d
Cleared Sep 27, 1978
PLASTI-PORE SEPTAL BUTTON
K781574 · FZE
Richard'S Medical Equip., Inc.
General & Plastic Surgery · 9d
Cleared Sep 27, 1978
DISPOSABLE CARDIOTOMY
K781577 · DTN
C.R. Bard, Inc.
Cardiovascular · 12d
Cleared Sep 27, 1978
BODY-WORN HEARING AID, MODEL 787PP
K781595 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
HEARING AID, MODEL 775 PP/AGC
K781596 · ESD
Danavox, Inc.
Ear, Nose, Throat · 12d
Cleared Sep 27, 1978
PM 2000 AUTOMATIC PATIENT CHAIR
K781597 · FFG
Time Motion System Co.
Gastroenterology & Urology · 12d
Cleared Sep 27, 1978
CENTRAL PEG TIBIAL COMPONENT
K781608 · HRY
Howmedica Corp.
Orthopedic · 9d
Cleared Sep 26, 1978
DLC 500, DOUBLE LUMEN CATHETER
K781050 · KOC
Hemodialysis, Division of The
Gastroenterology & Urology · 97d
Cleared Sep 26, 1978
MUSCLE STIMULATOR, ELECTRICAL
K781113 · IPF
Rich-Mar Corp.
Physical Medicine · 85d
Cleared Sep 26, 1978
MUSCLE STIMULATOR, ELECTRONIC
K781139 · IPF
Thor Medical Instruments, Inc.
Physical Medicine · 82d
Cleared Sep 26, 1978
ELECTRODE, DEIP.
K781163 · DRX
Datascope Corp.
Cardiovascular · 76d
Cleared Sep 26, 1978
MODEL 80032A, OBSTETRICAL TELEMETRY
K781359 · HGM
Hewlett-Packard Co.
Obstetrics & Gynecology · 50d
Cleared Sep 26, 1978
WATERPATH SCANNING OPTION
K781508 · IYO
G.D. Searle and Co.
Radiology · 25d
Cleared Sep 26, 1978
ZEE-FRAME
K781509 · JAY
Equilibrated Bio Systems, Inc.
Anesthesiology · 25d
Cleared Sep 26, 1978
FLOMETER
K781541 · CAX
Chemetron Medical Products, Inc.
Anesthesiology · 18d
Cleared Sep 20, 1978
CONNECTING TUBE, CONDUCTIVE, SURG.
K781127 · GAZ
Seamless Hospital Products Co.
General Hospital · 77d