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
158689–158712 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 26, 1982
PENTAX BRONCHOFIBERSCOPE #FB-19E
K822844 · EOQ
Pentax Precision Instrument Corp.
Ear, Nose, Throat · 33d
Cleared Oct 26, 1982
DISPOSABLE MICRO-INFUSION SYSTEM
K822928 · FMF
Orange Medical Instruments, Inc.
Microbiology · 22d
Cleared Oct 26, 1982
SCR WRAP
K822931 · FRG
Fox Converting, Inc.
General Hospital · 22d
Cleared Oct 26, 1982
NETILMICIN FLUORESCENT IMMUNOASSAY
K822941 · LCE
American Diagnostic Corp.
Chemistry · 22d
Cleared Oct 26, 1982
NEPTUNE
K822947 · EJH
Jeneric Ind.
Dental · 22d
Cleared Oct 26, 1982
SPHEREX E.C.T.
K822951 · EJJ
Jeneric Ind.
Dental · 22d
Cleared Oct 26, 1982
G CAST
K822956 · EJT
J. Aderer, Inc.
Dental · 21d
Cleared Oct 26, 1982
PURCAST
K822957 · EJH
J. Aderer, Inc.
Dental · 21d
Cleared Oct 26, 1982
SENATEK
K822993 · HST
American Health Tech., Inc.
Neurology · 14d
Cleared Oct 22, 1982
COMPLETE
K822145 · FZQ
Richard-Allan Medical Ind., Inc.
General & Plastic Surgery · 93d
Cleared Oct 22, 1982
LARYNGEAL SPATULAS
K822259 · EQH
Kelleher Corp.
Ear, Nose, Throat · 85d
Cleared Oct 22, 1982
ROTO REST KINETIC TREATMENT TABLE PEDIA
K822402 · IKZ
Kinetic Concepts, Inc.
Physical Medicine · 73d
Cleared Oct 22, 1982
DNA MEDICAL DURACATH
K822436 · BSO
Moorehead Hospital Products, Inc.
Anesthesiology · 70d
Cleared Oct 22, 1982
MINISAMPLER TM
K822508 · JKA
Bms, Inc.
Hematology · 63d
Cleared Oct 22, 1982
SUNGLASS LENSES
K822573 · HQG
ZEISS
Ophthalmic · 59d
Cleared Oct 22, 1982
OPERAND SUTURE REMOVAL TRAY
K822577
Medcare Products
General & Plastic Surgery · 58d
Cleared Oct 22, 1982
RAST ALLERCOAT ALLERGEN DISCS
K822613 · DGC
Kallestad Laboratories, Inc.
Immunology · 53d
Cleared Oct 22, 1982
PRE-SERT
K822706 · HPX
Allergan, Inc.
Ophthalmic · 45d
Cleared Oct 22, 1982
ANAEROBIC CARBON DIOXIDE
K822752 · BXK
Liquid Carbonic Corp.
Anesthesiology · 39d
Cleared Oct 22, 1982
BLOOD GAS MIXTURE
K822753 · BXK
Liquid Carbonic Corp.
Anesthesiology · 39d
Cleared Oct 22, 1982
CLINICAL GAS MIXTURE-FLAMMABLE
K822762 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
CLINICAL GAS MIXTURE-NON-FLAMMABLE
K822763 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
LUNG DIFFUSION MIXTURE
K822764 · BXK
Liquid Carbonic Corp.
Anesthesiology · 38d
Cleared Oct 22, 1982
MICRO-CRAFT OSCILLATING SAW HANDPIECE
K822790 · KIJ
Xomed, Inc.
Orthopedic · 37d