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
86929–86952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 02, 1999
PRO OSTEON IMPLANT 500R RESORBABLE BONE GRAFT SUBSTITUTE
K990131 · MQV
Interpore Cross Intl.
Orthopedic · 47d
Cleared Mar 02, 1999
SSA-320A JUST VISION 200/ SSA-325A JUST VISION
K990490 · IYO
Toshiba America Medical Systems, In.C
Radiology · 14d
Cleared Mar 01, 1999
TUTODROP 1 AND TUTODROP 2
K982098 · FPA
Myco Medical Supplies, Inc.
General Hospital · 259d
Cleared Mar 01, 1999
VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA)
K982738 · HIH
Gynecare, Inc.
Obstetrics & Gynecology · 207d
Cleared Mar 01, 1999
FIXATION SYSTEM
K983318 · GDW
General Surgical Innovations
General & Plastic Surgery · 161d
Cleared Mar 01, 1999
BIONAVIGATION SYSTEM FOR PLACEMENT OF ENTERAL FEEDING TUBES
K983476 · KNT
Navion Biomedical Corp.
Gastroenterology & Urology · 150d
Cleared Mar 01, 1999
VISUALINE II (ALSO KNOWN AS SUNLINE) PHENCYCLIDINE
K983790 · LCM
Sun Biomedical Laboratories, Inc.
Toxicology · 125d
Cleared Mar 01, 1999
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
K983817 · CAH
King Systems Corp.
General Hospital · 123d
Cleared Mar 01, 1999
PROVISIONAL DENTAL IMPLANT SYSTEM
K984287 · DZE
Nobel Biocare Uas, Inc.
Dental · 90d
Cleared Mar 01, 1999
`THE INSEMINATOR' (PROPOSED)
K984306 · MFD
Wallach Surgical Devices, Inc.
Obstetrics & Gynecology · 89d
Cleared Mar 01, 1999
HYPERGEL 20% HYPERTONIC SALINE GEL
K984370 · MGQ
Molnlycke Health Care, Inc.
General & Plastic Surgery · 84d
Cleared Mar 01, 1999
SUTURELESS ANCHOR
K984490 · MAI
Innovasive Devices, Inc.
Orthopedic · 74d
Cleared Mar 01, 1999
FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
K984539 · KMF
Ferris Mfg. Corp.
General & Plastic Surgery · 70d
Cleared Mar 01, 1999
SYNTEC-TAICHUNG NON-STERILE INTERLOCKING NAIL SYSTEM,...
K984543 · HSB
Syntec Scientific Corp.
Orthopedic · 70d
Cleared Mar 01, 1999
PRE-THREADED ENDOBUTTON
K984550 · GAT
Smith & Nephew, Inc.
General & Plastic Surgery · 69d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA THIN DRESSING
K984593 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA HYDRO DRESSING
K984595 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA CAVITY DRESSING
K984597 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
MODIFICATION OF CUTINOVA FOAM DRESSING
K984599 · FRO
Beiersdorf-Jobt, Inc.
General & Plastic Surgery · 63d
Cleared Mar 01, 1999
ANATOMICA GLENOID COMPONENT
K990136 · KWS
Sulzer Orthopedics, Inc.
Orthopedic · 46d
Cleared Mar 01, 1999
D-SIGN V (R&D PROJECT DW267#17)
K990182 · EJH
Ivoclar North America, Inc.
Dental · 40d
Cleared Mar 01, 1999
D-SIGN VI (R&D PROJECT DW266#9)
K990235 · EJH
Ivoclar North America, Inc.
Dental · 35d
Cleared Feb 26, 1999
BIRTCHER UV LAMP
K973865 · MXG
Medfaxx, Inc.
General & Plastic Surgery · 508d
Cleared Feb 26, 1999
MEDCOMP TESIO CATHETER, MODELS MBR-6, MBL-6, MBS-6
K981125 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 336d