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
155641–155664 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 05, 1983
WISDOM AIRWAY
K833482 · CAE
Wisdom Corp.
Anesthesiology · 59d
Cleared Dec 03, 1983
DERMATOLOGY HANDPIECE-OPHTH LASER
K833274 · HQF
Synemed, Inc.
Ophthalmic · 73d
Cleared Dec 02, 1983
MACLEAN-FOGG, TISSUE CASSETTES
K833857 · IDZ
Polymer Technology Corp.
Pathology · 25d
Cleared Dec 01, 1983
PATIENT MONITOR CM 135
K831164 · DRT
Honeywell, Inc.
Cardiovascular · 234d
Cleared Dec 01, 1983
BIOSENSOR ASC SYSTEM
K831676 · DSI
Biosensor Corp.
Cardiovascular · 192d
Cleared Dec 01, 1983
G-2000
K832227 · DPS
Eaton Medical Group
Cardiovascular · 146d
Cleared Dec 01, 1983
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K832374 · JOM
Sonicaid, Inc.
Cardiovascular · 136d
Cleared Dec 01, 1983
SHILEY M2000 MEMBRANE OXYGENATOR
K833253 · DTZ
Shiley, Inc.
Cardiovascular · 72d
Cleared Dec 01, 1983
NAMIC CONTINUOUS FLUSH DEVICE
K833271 · DRS
North American Instrument Corp.
Cardiovascular · 71d
Cleared Dec 01, 1983
AUDIT V AX 135
K833298 · GWK
Axonics, Inc.
Neurology · 69d
Cleared Dec 01, 1983
PREPARED MUELLER HINTON MED/100 MM
K833506 · JTZ
Lavco Laboratory, Inc.
Microbiology · 51d
Cleared Dec 01, 1983
PREPARED TRYPTIC SOY AGAR 100 MM PLATE
K833507 · JSG
Lavco Laboratory, Inc.
Microbiology · 51d
Cleared Dec 01, 1983
OPTIMA MDT PULSE GENERATOR W/TELEMETRY
K833798 · DXY
Telectronics, Inc.
Cardiovascular · 31d
Cleared Dec 01, 1983
NEURAL STIMULATOR MONITOR
K833809 · GZB
Instromedix, Inc.
Neurology · 29d
Cleared Dec 01, 1983
HOLTER PERFORMER FEATHER WEIGHT/CASS
K833823 · DSH
Applied Cardiac Systems
Cardiovascular · 29d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824 · DTB
Pacesetter Systems
Cardiovascular · 31d
Cleared Nov 30, 1983
SOLUTION ADMINISTRATION LINE W/SPIKE
K833178 · FPA
Intramed, Inc.
General Hospital · 72d
Cleared Nov 29, 1983
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
K830197 · KLK
Diamond Shamrock Corp.
Anesthesiology · 313d
Cleared Nov 29, 1983
MBS HARD TISSUE REPLACEMENT SYSTEM
K832509 · LYC
Medical Biological Sciences, Inc.
Dental · 125d
Cleared Nov 29, 1983
SYSTENET
K832544 · KGX
American Intl. Medical Supply Co.
General & Plastic Surgery · 123d
Cleared Nov 29, 1983
WINDSOR MEDICAL VARIOUS MODELS
K832606 · FRN
Windsor Medical, Inc.
General Hospital · 118d
Cleared Nov 29, 1983
POINTER F-3
K833037 · GZJ
Petra Intl. Co.
Neurology · 83d
Cleared Nov 29, 1983
HOBBS MEDICAL RETRIEVAL BASKET
K833124 · OCZ
Hobbs Medical, Inc.
Gastroenterology & Urology · 77d
Cleared Nov 29, 1983
TRICON M TOTAL KNEE SYSTEM
K833200 · MBV
Richards Medical Co., Inc.
Orthopedic · 71d