FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
136753–136776 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 22, 1988
PLAYTEX PORTABLE NON-DEOD. & DEOD REGULAR & SUPER
K881057 · HIL
Playtex, Inc.
Obstetrics & Gynecology · 11d
Cleared Mar 21, 1988
LASE EVACUATOR/ASPIRATOR
K874157 · BTA
Lase, Inc.
General & Plastic Surgery · 160d
Cleared Mar 21, 1988
MICROSHEV MODEL 2000
K874193 · GWJ
Micro-Shev , Ltd.
Neurology · 159d
Cleared Mar 21, 1988
SARA DIGICAP
K874754 · CCK
Ppg/Applied Resources, Inc.
Anesthesiology · 124d
Cleared Mar 21, 1988
CM 3000 THE MONITOR
K874898 · BZQ
Lifeline Medical Systems, Inc.
Anesthesiology · 111d
Cleared Mar 21, 1988
HEALTH CARE EYE PROTECTION
K875107 · HOY
Surgikos, Inc.
Ophthalmic · 98d
Cleared Mar 21, 1988
MEDICAL EYE DISPOSABLE SHIELD
K875302 · HOY
Bfd, Inc.
Ophthalmic · 83d
Cleared Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Abbott Laboratories
Immunology · 82d
Cleared Mar 21, 1988
PLEUR-EVAC--A-5002 CHEST DRAINAGE SYSTEM W/AUTO
K880162 · CAC
Deknatel, Inc.
Anesthesiology · 68d
Cleared Mar 21, 1988
ROVENSTEIN FORCEPS
K880318 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 21, 1988
MAGILL FORCEPS
K880319 · BWB
Eastmed Enterprises, Inc.
Anesthesiology · 55d
Cleared Mar 21, 1988
CERION OXY THRESHOLD ALARM
K880448 · CCL
Ceramatec, Inc.
Anesthesiology · 48d
Cleared Mar 21, 1988
3M XP515 X-RAY FILM PROCESSOR
K880563 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
3M XP 505 X-RAY FILM PROCESSOR
K880564 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES
K880565 · IXW
3M Company
Radiology · 40d
Cleared Mar 21, 1988
MSI-PC
K880608 · GJP
Medical Specialties, Inc.
Hematology · 38d
Cleared Mar 21, 1988
RETICCOUNT SOFTWARE
K880636 · GKL
Bd Becton Dickinson Vacutainer...
Hematology · 34d
Cleared Mar 21, 1988
MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
K880682 · BSJ
King Systems Corp.
Anesthesiology · 31d
Cleared Mar 21, 1988
DYONICS DRILL GUIDE/ISOMETER SYSTEM
K880739 · LXI
Dyonics, Inc.
Orthopedic · 26d
Cleared Mar 21, 1988
SURGICAL BURS
K880859 · GFF
New England Surgical Instrument Corp.
General & Plastic Surgery · 20d
Cleared Mar 21, 1988
MEDI-LET
K880869 · FMK
Medicore, Inc.
General & Plastic Surgery · 20d
Cleared Mar 21, 1988
MAMMOGRAPHY MOVING GRID BUCKY
K880905 · IZH
Custom Medical Products, Ltd.
Radiology · 19d
Cleared Mar 21, 1988
REPAK SURGICAL PACK (GOWN,TOWEL,MAJOR,DRAPE,BASIC)
K880942 · LRO
Repack Surgical Enterprises, Inc.
General & Plastic Surgery · 14d
Cleared Mar 21, 1988
SPRING RETRACTOR
K880997 · GAD
T. Korossurgical Instruments Corp.
General & Plastic Surgery · 13d