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
88705–88728 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 14, 1998
PICTOOLS MEDICAL TOOL KIT MODEL 1.0
K982146 · LLZ
Pegasus Imaging Corp.
Radiology · 89d
Cleared Sep 14, 1998
SHERLOCK THREADED SUTURE ANCHOR (TIN COATED)
K982169 · MBI
Doctor'S Research Group, Inc.
Orthopedic · 87d
Cleared Sep 14, 1998
CHEMICAL CURE COMPOSITE WITH ENAMEL BOND
K982191 · EBF
Medental Intl.
Dental · 84d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM
K982320 · KWP
Depuy, Inc.
Orthopedic · 74d
Cleared Sep 14, 1998
SURGI STIM
K982388 · IPF
Vision Quest Industries, Inc.
Physical Medicine · 67d
Cleared Sep 14, 1998
CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE)
K982390 · KTW
Wrightmedicaltechnologyinc
Orthopedic · 67d
Cleared Sep 14, 1998
VISIVOX, MODEL V-2
K982396 · LEZ
Rsq, LLC
Ear, Nose, Throat · 67d
Cleared Sep 14, 1998
AEROTEE, MODEL # 1001
K982408 · CAF
Piper Medical Products
Anesthesiology · 66d
Cleared Sep 14, 1998
FIBER OPTIC ENDOILLUMINATION PROBE
K982462 · FFS
Microvision, Inc.
Gastroenterology & Urology · 61d
Cleared Sep 14, 1998
DEPUY MOTECH PEAK FIXATION SYSTEM
K982483 · HRS
DePuy Orthopaedics, Inc.
Orthopedic · 59d
Cleared Sep 14, 1998
DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS
K982511 · KWP
Depuy, Inc.
Orthopedic · 56d
Cleared Sep 14, 1998
OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL
K982601 · HSB
Osteonics Corp.
Orthopedic · 49d
Cleared Sep 14, 1998
RETROGRADE ROD SYSTEM
K982602 · HSB
Howmedica Corp.
Orthopedic · 49d
Cleared Sep 14, 1998
DORNIER MEDILAS D
K982629 · GEX
Dornier Surgical Products, Inc.
General & Plastic Surgery · 48d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH, ONE PIECE AND ONE PIECE...
K982742 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, PUSH BUTTON WITH AND WITHOUT HOLSTER, MODEL...
K982743 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
MONOPOLAR SUCTION COAGULATOR, MODEL # SB 110-1
K982746 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
MONOPOLAR FOOT CONTROL PENCIL, MODEL # SB 112-2
K982749 · GEI
New Deantronics Taiwan , Ltd.
General & Plastic Surgery · 39d
Cleared Sep 14, 1998
DERMA K ER:YAG/CO2 LASER
K982827 · GEX
Esc Medical Systems, Inc.
General & Plastic Surgery · 34d
Cleared Sep 14, 1998
DISPOSABLE HAND SWITCHING PENCIL, ROCKER SWITCH TWO PIECE, SB 312RS, TWO...
K982884 · GEI
New Deantronics, Ltd.
General & Plastic Surgery · 28d
Cleared Sep 14, 1998
CARBON DIOXIDE-SL ASSAY, CAT # 253-01
K983019 · KHS
Diagnostic Chemicals , Ltd.
Chemistry · 14d
Cleared Sep 14, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
K983127 · DIF
Medical Analysis Systems, Inc.
Toxicology · 6d
Cleared Sep 11, 1998
INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED)
K980578 · DYB
Innerdyne, Inc.
Cardiovascular · 206d
Cleared Sep 11, 1998
FOAM TIP INJECTOR
K980696 · MSS
Staar Surgical Co.
Ophthalmic · 200d