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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
166705–166728 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 02, 1980
MEDSPEC SAFETY PINS
K800278 · KKX
Medspec Corp.
General Hospital · 87d
Cleared May 02, 1980
MEDSPEC RUBBER BANDS
K800279
Medspec Corp.
General Hospital · 87d
Cleared May 02, 1980
GAMBRO LUNDIA FIBER
K800336 · FJI
Gambro, Inc.
Gastroenterology & Urology · 77d
Cleared May 02, 1980
PULSE GENERATORS MODELS 657 & 677
K800387 · DXY
Siemens Elema AB
Cardiovascular · 70d
Cleared May 02, 1980
HELENA COLOCHECK
K800433 · KHE
Helena Laboratories
Hematology · 65d
Cleared May 02, 1980
MOD. 3127 NEUROMUSCULAR STIMULATOR
K800484 · IPF
Medtronic Vascular
Physical Medicine · 59d
Cleared May 02, 1980
GENERAL ELECTRIC RADVIEW MARK I SYSTEM
K800564 · KPR
General Electric Co.
Radiology · 50d
Cleared May 02, 1980
HYFRECATOR, #733
K800617 · GEI
Birtcher Corp.
General & Plastic Surgery · 45d
Cleared May 02, 1980
MODEL 118 PULSE MEGASON
K800632 · IMI
Birtcher Corp.
Radiology · 43d
Cleared May 02, 1980
BVN
K800695 · ITG
Donald J. Mangus, M.D.
Physical Medicine · 35d
Cleared May 02, 1980
SUNHOUSE UVB ULTRAVIOLET LIGHT TANNING
K800697
Progressive Productions , Ltd.
Radiology · 35d
Cleared May 02, 1980
OHC DYNAMIC CLUB FOOT BRACE
K800715 · IQI
Ipos Luneburg
Physical Medicine · 32d
Cleared May 02, 1980
ORTHOTIC LEG GAIT CORRECTOR DEVICE
K800716 · ITO
Ipos Luneburg
Physical Medicine · 32d
Cleared May 02, 1980
CELLIBIOSE-ARGININE-LYSINE AGAR (CAL)
K800745 · JSI
Remel Co.
Microbiology · 29d
Cleared May 02, 1980
SHIELD DISP. REINFORCED DRAPE SHEETS
K800817 · KKX
American Convertors Div., American...
General Hospital · 21d
Cleared May 02, 1980
HEMESPEC CHECK SET
K800852 · KRZ
Helena Laboratories
Hematology · 17d
Cleared May 02, 1980
SNYDER HEMOVAC CHEST DRAINAGE SOLUTION
K800861 · KDQ
Snyder Laboratories, Inc.
General Hospital · 16d
Cleared May 02, 1980
TRICYCLIC ANTIDEPRESSANTS I TX CONTROL
K800888 · DIF
Utak Laboratories, Inc.
Toxicology · 15d
Cleared May 02, 1980
DUPUY CEMENT RESTRICTOR TRIALS & INSTR.
K800894 · JDI
Depuy, Inc.
Orthopedic · 14d
Cleared May 02, 1980
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898 · JDS
Dow Corning Corp. Healthcare...
Orthopedic · 14d
Cleared May 02, 1980
TRU-COLD THERAPY PAK
K800917 · IME
Tru-Eze Mfg. Co., Inc.
Physical Medicine · 10d
Cleared May 02, 1980
PERSONAL SITZ BATH KIT
K800958 · KTC
The Healthcare Group Laboratories, Inc.
Physical Medicine · 9d
Cleared May 02, 1980
AUSTRY ALLOY(DENTAL BAKE-ON ALLOY)
K800994 · EJS
Howmedica Corp.
Dental · 7d
Cleared May 02, 1980
FLOW MED 160
K801004 · FPA
D.R.O. Medical, Inc.
General Hospital · 7d