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
72817–72840 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 26, 2003
WINGED NEEDLE SETS WITH AN ANTINEEDLE STICK PROTECTOR
K023917 · FPA
Kawasumi Laboratories, Inc.
General Hospital · 93d
Cleared Feb 26, 2003
CONTAFLEX 38 (POLYMACON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023987 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
CONTAFLEX 55 (METHAFILCON) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR...
K023989 · LPL
Contamac, Ltd.
Ophthalmic · 86d
Cleared Feb 26, 2003
VERTE-SPAN SPINAL SYSTEM
K024049 · MQP
Medtronic Sofamor Danek, Inc.
Orthopedic · 79d
Cleared Feb 26, 2003
SMITH & NEPHEW FEMORAL HEADS
K024340 · JDI
Smith & Nephew, Inc.
Orthopedic · 61d
Cleared Feb 26, 2003
B.07 STAIRWAY CHAIRLIFT
K024345 · ILK
Services Industriels Savaria, Inc.
Physical Medicine · 61d
Cleared Feb 26, 2003
DISPOSABLE VITRECTOMY SETS, DISPOSABLE VIRECTOMY LENSES
K030054 · HJK
Fci Ophthalmics, Inc.
Ophthalmic · 51d
Cleared Feb 26, 2003
MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
K030141 · DTQ
Cardiovention, Inc.
Cardiovascular · 42d
Cleared Feb 26, 2003
CALCIGEN PSI BONE GRAFT SUBSTITUTE
K030178 · MQV
Biomet, Inc.
Orthopedic · 40d
Cleared Feb 26, 2003
VICTUS I.V. ADMINISTRATION SET, MODELS 27071 AND 27072
K030246 · FPA
Victus, Inc.
General Hospital · 33d
Cleared Feb 26, 2003
INTERFERENTIAL STIMULATOR, MODEL RTM1000
K030254 · IPF
Ryan Telemedicine
Physical Medicine · 33d
Cleared Feb 26, 2003
QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030
K030264 · DTZ
Jostra AG
Cardiovascular · 30d
Cleared Feb 26, 2003
HERMETIC PLUS EXTERNAL CSF DRAINAGE SYSTEMS, INS-8301,INS-8302,INS-8700,...
K030289 · JXG
Integra Lifesciences Corp.
Neurology · 29d
Cleared Feb 26, 2003
HEM-O-LOK XL CLIP
K030311 · FZP
Weck
General & Plastic Surgery · 27d
Cleared Feb 26, 2003
ZEPHIR ANTERIOR CERVICAL SYSTEM
K030327 · KWQ
Medtronic Sofamor Danek
Orthopedic · 26d
Cleared Feb 26, 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · MNH
Depuyacromed
Orthopedic · 21d
Cleared Feb 26, 2003
MODIFICATION TO DASH 3000/4000 PATIENT MONITOR
K030431 · MHX
Ge Medical Systems Information...
Cardiovascular · 16d
Cleared Feb 26, 2003
MODIFICATION TO THE MAESTRO SYSTEM
K030463 · DZE
BioHorizons Implant Systems, Inc.
Dental · 14d
Cleared Feb 26, 2003
SENORX ES-300
K030473 · GEI
Senorx, Inc.
General & Plastic Surgery · 14d
Cleared Feb 25, 2003
JAX
K010555 · MQV
Smith & Nephew, Inc.
Orthopedic · 729d
Cleared Feb 25, 2003
U2 ACETABULAR CUP
K022520 · LPH
United Orthopedic Corp.
Orthopedic · 210d
Cleared Feb 25, 2003
NAVIGUS II TRAJECTORY GUIDE WITH VERIFICATION RETICULES
K023949 · HAW
Image-Guided Neurologics, Inc.
Neurology · 90d
Cleared Feb 25, 2003
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE...
K024100 · LIH
Theratech, Inc.
Neurology · 75d
Cleared Feb 25, 2003
MICROSURGICAL BIPOLAR HANDPIECE
K024304 · GEI
Neomedix Corp.
General & Plastic Surgery · 63d