FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
89425–89448 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared May 08, 1998
COZUMEL DIAGNOSTIC ULTRASOUND SYSTEM
K981505 · IYO
Sonosite,Inc.
Radiology · 14d
Cleared May 08, 1998
SONOACE 6000/ ULTRAMARK 400
K981510 · IYO
Medison America, Inc.
Radiology · 10d
Cleared May 07, 1998
QUICK CHECK INSTANT THERMOMETER
K971831 · FLL
Ejb Medical, Inc.
General Hospital · 356d
Cleared May 07, 1998
BIRD SENTRY BLENDER/ ANALYZER / BIRD SENTRY LOW FLOW BLENDER/ANALYZER
K973646 · BZR
Bird Products Corp.
Anesthesiology · 225d
Cleared May 07, 1998
CONTROLLED TEMPERATURE CABINET SYSTEM
K973747 · LDQ
Smith
General & Plastic Surgery · 218d
Cleared May 07, 1998
FRIOS BONESHIELD
K973924 · JEY
Friatec AG
Dental · 204d
Cleared May 07, 1998
TRIMPORT
K974533 · LJT
Gerard Medical, Inc.
General Hospital · 156d
Cleared May 07, 1998
MUSE CARDIOVASCULAR INFORMATION SYSTEM
K980495 · LOS
Marquette Medical Systems, Inc.
Cardiovascular · 87d
Cleared May 07, 1998
QUIKSTRIP ONE STEP PHENCYCLIDINE (PCP) TEST
K981019 · LCM
Syntron Bioresearch, Inc.
Toxicology · 50d