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
88945–88968 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1998
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS 2 AND 3
K982024 · DIF
Medical Analysis Systems, Inc.
Toxicology · 20d
Cleared Jun 29, 1998
I-STAT LACTATE TEST
K982071 · KHP
I-Stat Corp.
Chemistry · 17d
Cleared Jun 26, 1998
DIALOG DIALYSIS MACHINE
K963440 · KDI
B. Braun Medical AG
Gastroenterology & Urology · 665d
Cleared Jun 26, 1998
CORPAK MEDSYSTEMS CRUZ CATHETER FOR PERITONEAL DIALYSIS
K964514 · FKO
Corpak, Inc.
Gastroenterology & Urology · 605d
Cleared Jun 26, 1998
LIFE SUPPORT FOR TRAUMA AND TRANSPORT
K965117 · MKJ
Northrop Grumman Corp.
Cardiovascular · 553d
Cleared Jun 26, 1998
CARDIMA VUEPORT CORONARY SINUS BALLOON OCCLUSION GUIDING CATHETER
K973298 · DQY
Cardima, Inc.
Cardiovascular · 297d
Cleared Jun 26, 1998
PASSPORT 5L-CE MODEL 0998-00-0131XXX
K974178 · DRT
Datascope Corp.
Cardiovascular · 232d
Cleared Jun 26, 1998
PHYTACARE ALGINATE HYDROGEL WOUND DRESSING
K980132 · MGQ
Phytatek Laboratories, Inc.
General & Plastic Surgery · 162d
Cleared Jun 26, 1998
THALAFIX NATURAL SEA SALT DRESSING
K980779 · KMF
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 116d
Cleared Jun 26, 1998
RELIANCE LONG STEM FEMORAL COMPONENTS
K980813 · JDI
Howmedica, Inc.
Orthopedic · 115d
Cleared Jun 26, 1998
PATHFINDER MOBILE C ARM
K981131 · OXO
Acoma Medical Imaging, Inc.
Radiology · 88d
Cleared Jun 26, 1998
OSTEOGRAF/N-700
K981214 · LYC
Ceramed Dental, LLC
Dental · 85d
Cleared Jun 26, 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER H134
K981728 · BZQ
Alexander Mfg. Co.
Anesthesiology · 42d
Cleared Jun 26, 1998
SILIMED NASAL L SHAPED IMPLANT
K981833 · FZE
Silimed, LLC
General & Plastic Surgery · 31d
Cleared Jun 26, 1998
SURGIFLATOR-20 ECU
K981859 · HIF
W.O.M. World of Medicine GmbH
Obstetrics & Gynecology · 30d
Cleared Jun 25, 1998
CROSS MEDICAL BONE PLATE SYSTEM/ CM BONE PLATE SYSTEM/CROSS TI BONE PLATE SYSTEM
K961320 · HWC
Buckman Co., Inc.
Orthopedic · 811d
Cleared Jun 25, 1998
BECTON DICKINSON SYRINGES
K980580 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 128d
Cleared Jun 25, 1998
VED VALU- VACUUM ERECTION DEVICE
K980948 · LKY
Mission Pharmacal Comp
Gastroenterology & Urology · 104d
Cleared Jun 25, 1998
MICROCAP
K981114 · CCK
Oridion Medical , Ltd.
Anesthesiology · 90d
Cleared Jun 25, 1998
RADIO-PLAST
K981115 · LHN
Smith & Nephew, Inc.
Radiology · 90d
Cleared Jun 25, 1998
CERALAS G FREQUENCY DOUBLED ND: YAG LASER SYSTEMS, CERALAS G3
K981126 · GEX
Ceram Optec, Inc.
General & Plastic Surgery · 90d
Cleared Jun 25, 1998
MINRAD DRTS LIGHT SABER SYRINGE
K981140 · FMF
Minrad, Inc.
General Hospital · 87d
Cleared Jun 25, 1998
CLEARPLAN EASY OVULATION TEST
K981271 · CEP
Unipath , Ltd.
Chemistry · 79d
Cleared Jun 25, 1998
SYNTHES (USA) RATCHETING DISTRACTOR
K981275 · MQN
Synthes (Usa)
Dental · 78d