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
89929–89952 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 11, 1998
PHILIPS GYROSCAN NT RELEASE 6 SERIES
K980645 · LNH
Philips Medical Systems North...
Radiology · 81d
Cleared May 11, 1998
AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE
K980691 · MOS
Hitachi Medical Systems America, Inc.
Radiology · 77d
Cleared May 11, 1998
SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE
K980704 · GAM
Aesculap, Inc.
General & Plastic Surgery · 77d
Cleared May 11, 1998
BOSTON EO RIGID GAS PERMEABLE CONTACT LENS MATERIAL (ENFLOFOCON B)
K980741 · HQD
Polymer Technology Div. Wilmington...
Ophthalmic · 74d
Cleared May 11, 1998
LUMISCAN 135 PHOSPHOR PLATE DIGITIZER/LUMISYS 135 ERASER
K980809 · LMA
Lumisys, Inc.
Radiology · 69d
Cleared May 11, 1998
SURGIDEV SILICONE PUNCTUM PLUG
K980844 · LZU
Advanced Vision Science
Ophthalmic · 68d
Cleared May 11, 1998
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
K980863 · KMF
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 67d
Cleared May 11, 1998
HAKOMED ELECDT / PRO ELEDT SERIES
K980892 · IPF
Alive, Inc.
Physical Medicine · 63d
Cleared May 11, 1998
SYNTHES SPINE UNIVERSAL SPINAL HOOK, ROD, PEDICLE/SACRAL SCREW FIXATION SYSTEM
K980928 · KWP
Synthes Spine
Orthopedic · 61d
Cleared May 11, 1998
REGENT BIOGEL INDICATOR INNER SURGICAL GLOVE
K980942 · KGO
London International Group, Inc.
General Hospital · 60d
Cleared May 11, 1998
HAKOMED ELECDT/VACUPULLS
K980958 · IPF
Alive, Inc.
Physical Medicine · 56d
Cleared May 11, 1998
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION...
K980963 · ELW
Foremost Dental Mfg., Inc.
Dental · 56d
Cleared May 11, 1998
PROCAD
K980986 · EIH
Ivoclar USA, Inc.
Dental · 55d
Cleared May 11, 1998
AXYA MEDICAL, INC. AUTOMATIC SUTURING AND LIGATING SYSTEM-(ASLS)
K980988 · GAB
Axya Medical, Inc.
General & Plastic Surgery · 55d
Cleared May 11, 1998
SOFSILK SUTURE
K981128 · GAP
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared May 11, 1998
OSTEO 4.0MM CANNULATED SCREW SYSTEM
K981259 · HWC
Osteonics Corp.
Orthopedic · 35d
Cleared May 11, 1998
INTERACOUSTICS MODEL AD226 DIAGNOSTIC AUDIOMETER
K981327 · EWO
Idem (Int'L Dist. of Electronics For...
Ear, Nose, Throat · 28d
Cleared May 11, 1998
SYNTHES 3.0 MM PC-FIX SYSTEM
K981372 · HWC
Synthes (Usa)
Orthopedic · 25d
Cleared May 11, 1998
ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE
K981392 · KGO
Ansell Perry
General Hospital · 24d
Cleared May 11, 1998
STERNGOLD IMPLAMED HEX SCREW IMPLANT TPS COATED STERNGOLD IMPLAMED HEX SCREW...
K981516 · DZE
Sterngold/Implamed
Dental · 13d
Cleared May 08, 1998
PRINCESS SYRINGE
K980577 · EIA
Sodexco
Dental · 80d
Cleared May 08, 1998
KSEA PLASTIC TROCARS
K980694 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 74d
Cleared May 08, 1998
ENDO FMS UROLOGY
K980808 · LJH
Future Medical Systems, Inc.
Gastroenterology & Urology · 66d
Cleared May 08, 1998
IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
K981403 · DKB
Beckman Instruments, Inc.
Toxicology · 21d