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
85249–85272 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 09, 1999
ATAC-PAK DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
K991789 · LBR
Elan Holdings, Inc.
Chemistry · 45d
Cleared Jul 09, 1999
OPTIBOND SOLO PLUS 2
K991808 · KLE
Sybron Dental Specialties, Inc.
Dental · 43d
Cleared Jul 08, 1999
VIEWPOINT TOOLS- STERRAD
K983764 · HAW
Philips Medical Systems (Cleveland),...
Neurology · 255d
Cleared Jul 08, 1999
ATLAS MONITOR
K984033 · DRT
Welch Allyn, Inc.
Cardiovascular · 238d
Cleared Jul 08, 1999
QUALISYS PSA IMMUNOASSAY
K990234 · LTJ
Qualisys Diagnostics, Inc.
Immunology · 164d
Cleared Jul 08, 1999
STAINLESS STEEL SOFT SUTURE WIRE
K990355 · LRN
Bregma International Trading Company...
Orthopedic · 153d
Cleared Jul 08, 1999
EVENTSTATION ECG TRANS-TELEPHONIC RECEIVING SYSTEM
K991211 · DXH
Reynolds Medical , Ltd.
Cardiovascular · 90d
Cleared Jul 08, 1999
MTI 1 ML SYRINGE
K991225 · FMF
Micro Therapeutics, Inc.
General Hospital · 87d
Cleared Jul 08, 1999
SOFTRANS TEMP INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS TEMP...
K991235 · KXO
Ludlow Technical Products
Obstetrics & Gynecology · 87d
Cleared Jul 08, 1999
FCI CRAWFORD PROBE INTUBATION SETS
K991238 · OKS
Fci Ophthalmics, Inc.
Ophthalmic · 87d
Cleared Jul 08, 1999
THERMOPLATE
K991263 · MQG
Tokai Hit Co., Ltd.
Obstetrics & Gynecology · 86d
Cleared Jul 08, 1999
SPERM MAINTENANCE MEDIUM WITH GLYCEROL
K991337 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
ISOLATE, ISOLATE CONCENTRATE, ISOLATE STOCK SOLUTION
K991341 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
PBS 1X- DULBECCO'S PHOSPHATE BUFFERED SALINE SOLUTION
K991342 · MQL
Irvine Scientific Sales Co., Inc.
Obstetrics & Gynecology · 80d
Cleared Jul 08, 1999
ISOLUX SURGICAL HEADLIGHT
K991572 · FST
Isolux America
General & Plastic Surgery · 64d
Cleared Jul 08, 1999
C-LEG (3C100)
K991590 · ISW
Otto Bock Orthopedic Industry, Inc.
Physical Medicine · 62d
Cleared Jul 08, 1999
TITANIUM LOW PROFILE SCREWS
K991807 · LPH
Biomet, Inc.
Orthopedic · 43d
Cleared Jul 08, 1999
VOLUSION SMALL PARTS TRANSDUCER, MODEL S-VNW 5-10, VOLUSION ABDOMINAL...
K992155 · ITX
Medison America, Inc.
Radiology · 13d
Cleared Jul 07, 1999
SPECIALITY 55 MULTIFOCAL (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES...
K984090 · LPL
Specialty Ultravision, Inc.
Ophthalmic · 233d
Cleared Jul 07, 1999
RAPIDONE - MARIJUANA TEST
K990818 · LDJ
American Bio Medica Corp.
Toxicology · 118d
Cleared Jul 07, 1999
VISER PENILE TUMESCENCE MONITOR
K991479 · LIL
Laborie Medical Tech Corp.
Gastroenterology & Urology · 70d
Cleared Jul 07, 1999
BISTITE II SC
K991711 · EMA
Tokuyama America, Inc.
Dental · 49d
Cleared Jul 07, 1999
N LATEX IGE MONO REAGENT
K991787 · DGC
Dade Behring, Inc.
Immunology · 43d
Cleared Jul 07, 1999
NON-STERILE POWDER-FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING...
K991849 · LYY
Seal Polymer Industries Bhd.
General Hospital · 36d