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
170857–170880 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 14, 1978
CLINIRIA TOTAL T-4 (RIA) TEST
K781181 · CDX
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Aug 14, 1978
MICRO THYROXINE REAGENT SYSTEM
K781182 · CDX
Bd Becton Dickinson Vacutainer...
Chemistry · 31d
Cleared Aug 14, 1978
MONITOR, OXYGEN, MODEL 3000A
K781209 · CCL
Oxyair Engineering, Inc.
Anesthesiology · 31d
Cleared Aug 14, 1978
HEARING AID, MODEL 783DU
K781212 · ESD
Danavox, Inc.
Ear, Nose, Throat · 28d
Cleared Aug 14, 1978
IV ARMBOARDS
K781233 · BTX
Fibre Formations, Inc.
General & Plastic Surgery · 26d
Cleared Aug 14, 1978
IV VITRO GAMMADAB T4 RIA KIT
K781235 · CDX
Clinical Assays, Inc.
Immunology · 26d
Cleared Aug 14, 1978
UNISTAT BILIRUBINOMETER
K781241 · JJQ
American Optical Corp.
Chemistry · 26d
Cleared Aug 14, 1978
VENTILATION TUBE SILI. SHEPPARD TYPE
K781257 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE. SILI. DONALDSON TYPE
K781258 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE TEFLON SHEPARD TYPE
K781259 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
VENTILATION TUBE SILICONE PAPARELLA TYPE
K781260 · ETD
Xomed, Inc.
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
CHAIR, VESTIBULAR, ROTARY, COMPUT.
K781268 · LXV
Contraves
Ear, Nose, Throat · 21d
Cleared Aug 14, 1978
READER, INOCULUM, STDIZED.
K781283
Analytical Products, Inc.
Microbiology · 19d
Cleared Aug 14, 1978
INSULIN RIA KIT
K781285 · CFP
Serono Laboratories, Inc.
Immunology · 19d
Cleared Aug 14, 1978
PROSTHESIS, KNEE, TOTAL
K781294 · JWH
Biomet, Inc.
Orthopedic · 18d
Cleared Aug 14, 1978
TRANSPORT MEDIA
K781304 · JSN
Bd Becton Dickinson Vacutainer...
Microbiology · 18d
Cleared Aug 14, 1978
CAST SHOE
K781363 · IPG
Cutler Biomedical
Physical Medicine · 7d
Cleared Aug 14, 1978
SPARTA BRONCHIAL BRUSH
K781365 · KTI
Sparta Instrument Corp.
Ear, Nose, Throat · 7d
Cleared Aug 11, 1978
CONJUGATED BILE ACIDS RIA KIT
K781337 · KWW
Bd Becton Dickinson Vacutainer...
Chemistry · 8d
Cleared Aug 10, 1978
ELECTRONIC CLINICAL THERMOMETER
K780861 · FLL
Trend Medical, Inc.
General Hospital · 71d
Cleared Aug 10, 1978
E-Z-JECTOR
K780883 · KZA
Harco Products
General Hospital · 72d
Cleared Aug 10, 1978
HYPO-GRIP
K780884 · KZA
Harco Products
General Hospital · 72d
Cleared Aug 10, 1978
AIR-FLO ALTERNATING PRESSURE PAD SYSTEM
K780906 · FNM
Gaymar Industries, Inc.
General Hospital · 69d
Cleared Aug 10, 1978
ULTRASOUND IMAGING SYSTEM
K780993 · GAD
Boehringer Mannheim Corp.
Radiology · 57d