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
106585–106608 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 1994
MICRO-TOUCH LATEX MEDICAL GLOVES
K943620 · LYY
Johnson & Johnson Medical, Inc.
General Hospital · 44d
Cleared Sep 09, 1994
AVL 988-4 ELECTROLYTE ANALYZER
K943702 · JFP
Avl Scientific Corp.
Chemistry · 42d
Cleared Sep 09, 1994
EZ-SCREEN:PCP
K943711 · LCM
Editek, Inc.
Toxicology · 39d
Cleared Sep 09, 1994
OPTIBOND-D
K943738 · KLE
Sybron Dental Specialties, Inc.
Dental · 38d
Cleared Sep 09, 1994
SOLDER AUROLITE CB
K943755 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Sep 09, 1994
SOLDER AUROLITE REPAIR
K943757 · EJT
Argen Precious Metals, Inc.
Dental · 38d
Cleared Sep 08, 1994
LIGHTING SOURCE SYSTEM
K923656 · HIC
Galenica Enterprises, Inc.
Obstetrics & Gynecology · 787d
Cleared Sep 08, 1994
AMSCO STERILE RECOVERIES ABSORBENT TOWELS
K931143 · KKX
Amsco Sterile Recoveries, Inc.
General Hospital · 552d
Cleared Sep 08, 1994
NON-BALLOON REPLACEMENT GASTROSTOMY KIT
K932295 · KNT
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 485d
Cleared Sep 08, 1994
MEDI-STIM, MODIFICATION
K933237 · GZJ
Mid-Canada Medical
Neurology · 441d
Cleared Sep 08, 1994
CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM
K934072 · KNY
Contour Fabricators of Florida, Inc.
Gastroenterology & Urology · 384d
Cleared Sep 08, 1994
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
K934741 · GIL
Clinical Controls, Inc.
Hematology · 342d
Cleared Sep 08, 1994
INNOVATIVE TECHNOLOGIES HYDROCOLLOID WOUND DRESSINGS
K941688 · FRO
Innovative Technologies , Ltd.
General & Plastic Surgery · 155d
Cleared Sep 08, 1994
FOLEY CATHETERIZATION TRAY
K942177 · FCM
Customed, Inc.
Gastroenterology & Urology · 127d
Cleared Sep 08, 1994
LIFESTYLE MULTIVUE-S (POLYMACON) SOFT HYDROPHILIC CONTACT LENS
K942494 · LPL
Permeable Technologies, Inc.
Ophthalmic · 106d
Cleared Sep 08, 1994
OCTOPAQUE UNIVERSAL
K942916 · IXQ
Octostop, Inc.
Radiology · 79d
Cleared Sep 08, 1994
MS CLASSIQUE BALLOON CATHETER
K943298 · LIT
Meadox Medicals, Div. Boston...
Cardiovascular · 62d
Cleared Sep 08, 1994
DISPOSABLE ESOPHAGEAL STETHOSCOPE
K943495 · BZT
Coast Medical, Inc.
Anesthesiology · 51d
Cleared Sep 08, 1994
NAVARRE 600 ML DRAINAGE BAG
K943663 · EXF
Navarre Biomedical , Ltd.
Gastroenterology & Urology · 42d
Cleared Sep 08, 1994
SURGI-LINK ENDOSCOPIC BIPOLAR FORCEPS
K944045 · GEI
Unimed Surgical Products, Inc.
General & Plastic Surgery · 21d
Cleared Sep 08, 1994
SPIROBAC ADAPTERS
K944124 · CAH
Mallinckrodt Medical
General Hospital · 16d
Cleared Sep 07, 1994
MICROCYCLER
K915166 · FCN
Medical Inventors Corp., Inc.
Gastroenterology & Urology · 1027d
Cleared Sep 07, 1994
ORTHOLOC ADVANTIM REVISION FEMORAL COMPONENT
K932210 · JWH
Dow Corning Wright
Orthopedic · 488d
Cleared Sep 07, 1994
GAMBRO LUNDIA PRO 100, 500, 600 DIALYZERS
K933681 · FJG
Cobe Renal Care, Inc.
Gastroenterology & Urology · 405d