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
159913–159936 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 14, 1982
COLORED WEDGE USED TO SEPARATE TEETH
K821444 · DZN
Moyco Industries, Inc.
Dental · 31d
Cleared Jun 14, 1982
NASAL-THROAT SPRAY IRRIGATION INSTRUM.
K821481 · ETP
Ethicare Products
Ear, Nose, Throat · 27d
Cleared Jun 14, 1982
DOWFLOW ALT-UV DETERMINATION
K821536 · CKA
The Dow Chemical Co.
Chemistry · 21d
Cleared Jun 14, 1982
MODEL AH BEHING-THE-EAR-HEARING AID
K821550 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 20d
Cleared Jun 14, 1982
DUALLOR 'R'
K821572 · EJS
J. Aderer, Inc.
Dental · 18d
Cleared Jun 14, 1982
DEN TEMP
K821581 · EMB
Majestic Drug Co., Inc.
Dental · 17d
Cleared Jun 14, 1982
EPISTAXIS CATHETER/KIT
K821584 · EMX
Bivona Medical Technologies
Ear, Nose, Throat · 13d
Cleared Jun 14, 1982
PORS-ON
K821590 · EJS
J. Aderer, Inc.
Dental · 13d
Cleared Jun 14, 1982
(125I) HTSH RADIOIMMUNOASSAY KIT
K821620 · JLW
Yang Laboratories, Inc.
Chemistry · 12d
Cleared Jun 14, 1982
NOVA IV FLUIDS PACK & EXTERNAL STANDARDS
K821623 · JIX
Shaban Mfg. Co.
Chemistry · 12d
Cleared Jun 14, 1982
ENDODONTIC PAPERPOINTS
K821625 · EKN
Roeko
Dental · 12d
Cleared Jun 14, 1982
FIXIDENT
K821629 · JET
Moyco Industries, Inc.
Dental · 12d
Cleared Jun 14, 1982
DOXEPIN TRI-CY TEST SET
K821652 · LFG
Wien Laboratories, Inc.
Chemistry · 11d
Cleared Jun 14, 1982
PROTRIPTYLINE TRI-CY TEST SET
K821653 · LFG
Wien Laboratories, Inc.
Chemistry · 11d
Cleared Jun 11, 1982
HAWKINS ELECTROKINETIC BODY ACTIVATING
K820938 · IPF
Leisure Way
Physical Medicine · 67d
Cleared Jun 11, 1982
VENTRE/SPEC ALLERGEN CONTROL-MOLDS/FOOD
K820977 · DGC
Ventrex Laboratories, Inc.
Microbiology · 66d
Cleared Jun 11, 1982
VENTRE/SPEC ALLERGEN CONTROL-INHALANT
K820978 · DGC
Ventrex Laboratories, Inc.
Microbiology · 66d
Cleared Jun 11, 1982
ESPREE' ANESTHESIA BACTERIAL FILTER
K821310 · CAH
Esp Plastics, Inc.
General Hospital · 38d
Cleared Jun 11, 1982
EMIT TIMER UNIT #100
K821531 · JQP
Syva Co.
Chemistry · 21d
Cleared Jun 11, 1982
TANDEM PROLACTIN KIT
K821545 · CFT
Hybritech, Inc.
Chemistry · 17d
Cleared Jun 11, 1982
PREG-KNOW
K821552 · JHJ
Immuno Pathology Labs
Chemistry · 17d
Cleared Jun 11, 1982
LANCER MSA BUN DIAG. KIT
K821562 · CDQ
Sherwood Medical Co.
Chemistry · 17d
Cleared Jun 11, 1982
PINCH GAUGE, 0-301 LBS.
K821631 · HRW
Fred Sammons, Inc.
Neurology · 8d
Cleared Jun 11, 1982
VARIABLE SPEED VIBRATOR, 120V 83-117 VIB
K821633 · IRO
Fred Sammons, Inc.
Physical Medicine · 8d