FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92785–92808 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 21, 1997
T-WALL UNCUFFED TRACHEAL TUBE
K970196 · BTR
Vital Signs, Inc.
Anesthesiology · 212d
Cleared Aug 21, 1997
SHIELDED SURGICAL TROCAR
K971475 · GCJ
Ethicon Endo-Surgery, Inc.
General & Plastic Surgery · 120d
Cleared Aug 21, 1997
ENDOXANE
K971509 · NWA
Novatech SA
General & Plastic Surgery · 118d
Cleared Aug 21, 1997
SCANNING DEVICE ACCESSORY FOR USE WITH THE CB DIODE/532 ND:YAG LASER
K971903 · GEX
Continuum Biomedical, Inc.
General & Plastic Surgery · 90d
Cleared Aug 21, 1997
TOA
K972061 · LRK
W. Keith Thornton, D.D.S.
Dental · 79d
Cleared Aug 21, 1997
INSIGHT 7000 PHASED ARRAY TORSO COIL
K972340 · MOS
Usa Instruments, Inc.
Radiology · 58d
Cleared Aug 21, 1997
MODEL 50 BIPOLAR COAGULATOR
K972350 · GEI
Boston Surgical Products, Inc.
General & Plastic Surgery · 58d
Cleared Aug 21, 1997
AD-HEAL HYDROGEL DRESSING, VARIOUS SIZES
K972646 · NAE
Ludlow Technical Products
General & Plastic Surgery · 37d
Cleared Aug 21, 1997
AXT 150M MANUAL COLLIMATOR (AXT 150M)
K972966 · IZX
Applied X-Ray Technologies, Inc.
Radiology · 10d
Cleared Aug 20, 1997
THE PERIOSEAL DENTAL IMPLANT
K965032 · DZE
Perioseal
Dental · 246d
Cleared Aug 20, 1997
DM-400 HOLTER ECG CASSETTE RECORDER
K970298 · DSH
Diagnostic Monitoring
Cardiovascular · 205d
Cleared Aug 20, 1997
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · LJZ
Zeus Scientific, Inc.
Microbiology · 118d
Cleared Aug 20, 1997
IMMUNOCARD STAT! ROTAVIRUS
K971585 · LIQ
Meridian Diagnostics, Inc.
Microbiology · 111d
Cleared Aug 20, 1997
CLARITHROMYCIN ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
K971638 · JTN
Oxoid , Ltd.
Microbiology · 110d
Cleared Aug 20, 1997
ACCU-SURG BI-POLAR ELECTRODES, L-HOOK, NEEDLE, BALL, BIPOLAR CORD
K971677 · GEI
Transamerican Technologies Intl.
General & Plastic Surgery · 105d
Cleared Aug 20, 1997
ASSET APOLLO
K971884 · LNH
Philips Medical Systems (Cleveland),...
Radiology · 90d
Cleared Aug 20, 1997
KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM
K971894 · LMA
Eastman Kodak Company
Radiology · 90d
Cleared Aug 20, 1997
JEJENOSTOMY FEEDING TUBE
K971906 · FPD
Boston Scientific Corp
Gastroenterology & Urology · 89d
Cleared Aug 20, 1997
SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT
K971958 · DDG
Beckman Instruments, Inc.
Immunology · 84d
Cleared Aug 20, 1997
EBI SPINELINK SYSTEM
K971970 · MNH
Electro-Biology, Inc.
Orthopedic · 83d
Cleared Aug 20, 1997
OSCULAR SCIENCES/ AMERICAN HYDRON, INC DAILY WEAR SOFT CONTACT LENS
K972303 · LPL
Ocular Sciences Puerto Rico, Inc.
Ophthalmic · 62d
Cleared Aug 20, 1997
MEDNEXT 1000 DRILL
K972308 · GEY
Mednext, Inc.
General & Plastic Surgery · 61d
Cleared Aug 20, 1997
NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A...
K972310 · DPS
Nihon Kohden America, Inc.
Cardiovascular · 61d
Cleared Aug 20, 1997
INNERWEAR, JIMMY-O RAINCOAT, RAINCOAT, JASMINE, DRINK
K972427 · HIS
Custom Services Intl., Inc.
Obstetrics & Gynecology · 54d