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
107809–107832 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 16, 1994
ENDO-NEEDLE INSTRUMENT
K936207 · GDM
Gerard Medical, Inc.
General & Plastic Surgery · 169d
Cleared Jun 16, 1994
FRESH FROZEN CELLS
K940502 · KIR
Diagnostic Hybrids, Inc.
Pathology · 134d
Cleared Jun 16, 1994
DEOX, OXYGEN BARRIER VISCOUS SOLUTION
K941065 · EMA
Ultradent Products, Inc.
Dental · 100d
Cleared Jun 16, 1994
MY BEAT POWERED TOOTHBRUSH
K941209 · JEQ
Sanwa Components USA, Inc.
Dental · 94d
Cleared Jun 16, 1994
N/T PROTEIN CONTROL SY/L, M, AND H
K941912 · JJY
Behring Diagnostics, Inc.
Immunology · 58d
Cleared Jun 16, 1994
LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH
K942209 · JCN
Bio-Rad
Hematology · 42d
Cleared Jun 16, 1994
ARGESOL-YSF PRE-SOLDER FOR HI GOLD DENT PORCEL ALLOYS
K942462 · EJT
Argen Precious Metals, Inc.
Dental · 23d
Cleared Jun 16, 1994
ARGESOL-WSF PRE-SOLDER FOR HIGH GOLD DENTAL PROCELAIN ALLOYS
K942505 · EJT
Argen Precious Metals, Inc.
Dental · 21d
Cleared Jun 16, 1994
ARGESOL-Y
K942507 · EJT
Argen Precious Metals, Inc.
Dental · 21d
Cleared Jun 16, 1994
ARGESOL-1040Y
K942538 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Jun 16, 1994
ARGESOL-LITE
K942539 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Jun 16, 1994
ARGESOL-WG
K942540 · EJT
Argen Precious Metals, Inc.
Dental · 20d
Cleared Jun 16, 1994
ARGESOL-1060W
K942557 · EJT
Argen Precious Metals, Inc.
Dental · 16d
Cleared Jun 16, 1994
ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND CEMENT
K942596 · EMA
Wallace A. Erickson & Co.
Dental · 15d
Cleared Jun 15, 1994
C-SECTION PACK
K921730 · KOH
Medikmark, Inc.
Obstetrics & Gynecology · 796d
Cleared Jun 15, 1994
MINOR LAP SET
K921732 · KOH
Medikmark, Inc.
Obstetrics & Gynecology · 796d
Cleared Jun 15, 1994
TRACHEOSTOMY CARE TRAY
K921733 · JOH
Medikmark, Inc.
Anesthesiology · 796d
Cleared Jun 15, 1994
VARIABLE ANGULAR HOLD BONE PLATE SYSTEM
K930480 · HRS
Smith & Nephew Richards, Inc.
Orthopedic · 502d
Cleared Jun 15, 1994
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T
K930876 · DTB
Siemens-Pacesetter, Inc.
Cardiovascular · 481d
Cleared Jun 15, 1994
TITAN DYSPLASIC TOTAL HIP PROSTHESIS
K932935 · LZO
Landos, Inc.
Orthopedic · 364d
Cleared Jun 15, 1994
CS-PLUS STEM
K936214 · JDI
Encore Orthopedics, Inc.
Orthopedic · 169d
Cleared Jun 15, 1994
BELTONE INVISA
K940098 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 156d
Cleared Jun 15, 1994
I-5000
K940662 · IOQ
Support Systems Intl.
Physical Medicine · 117d
Cleared Jun 15, 1994
INJECTION CAP
K940775 · FOZ
Medron, Inc.
General Hospital · 113d