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
147649–147672 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 08, 1985
SERVO HUMIDIFIER 153
K852601 · BYD
Siemens Elema AB
Anesthesiology · 19d
Cleared Jul 05, 1985
DERATA MEDI-JECTOR PRO
K844244 · KZE
Derata Corp.
General Hospital · 246d
Cleared Jul 05, 1985
CUTINOVA GELFILM SYNTHETIC WOUND DRESSING, STERILE
K850147 · FRO
Beiersdorf, Inc.
General & Plastic Surgery · 172d
Cleared Jul 05, 1985
BARD OCCLUSIVE WOUND DRESSING
K850889 · FRO
C.R. Bard, Inc.
General & Plastic Surgery · 123d
Cleared Jul 05, 1985
LATEX AGGLUTINATION TEST
K851132 · GTZ
New Horizons Diagnostics Co.
Microbiology · 106d
Cleared Jul 05, 1985
TELET-LEX MEDICAL IV CATHETER PLACEMENT
K851142 · FOZ
Teleflexmedical, Inc.
General Hospital · 106d
Cleared Jul 05, 1985
VERSAPHAGE
K851272 · HQE
Alphamedix, Inc.
Ophthalmic · 95d
Cleared Jul 05, 1985
DASS PACK
K851280 · GIF
Dass, Inc.
Hematology · 95d
Cleared Jul 05, 1985
SDI PREPAX DILUKIT M.
K851320 · GIF
Scientific Distributors, Inc.
Hematology · 94d
Cleared Jul 05, 1985
CHESEBROUGH-POND'S SEQUENTIAL WOUND DRESSING
K851382 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 88d
Cleared Jul 05, 1985
BLISTERFILM TRANSPARENT DRESSING
K851383 · NAD
Chesebrough-Pond'S U.S.A. Co.
General & Plastic Surgery · 88d
Cleared Jul 05, 1985
SUN FLOWER SOLETTE MINETTE NOVA SUPER 28X, PRO SER
K851408 · FTC
Applied Science, Inc.
General & Plastic Surgery · 87d
Cleared Jul 05, 1985
PULSE MED CUSTOM PKG. PROC. TRAYS OPERATING ROOMS
K851464 · FMF
Pulse Med, Inc.
General Hospital · 85d
Cleared Jul 05, 1985
MODEL DA BEHIND-THE-EAR HEARING AID
K851810 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 70d
Cleared Jul 05, 1985
VI-FLOW PUMP WITH VI-SET
K851821 · FRN
Vital Canada, Inc.
General Hospital · 70d
Cleared Jul 05, 1985
DAHLBERG MODEL DB BEHIND-THE-EAR HEARING AID
K851866 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 05, 1985
DAHLBERG MODEL DD BEHING-THE-EAR HEARING AID
K851867 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 05, 1985
DAHLBERG MODEL DC BEHIND-THE-EAR HEARING AID
K851869 · ESD
Miracle-Ear/Dahlberg, Inc.
Ear, Nose, Throat · 67d
Cleared Jul 05, 1985
CYTOLOGICAL CERVICAL SPATULA THE MULTI-SPATULA
K851934 · HHT
Tridak Division of Indicon, Inc.
Obstetrics & Gynecology · 60d
Cleared Jul 05, 1985
MODEL 145 FETAL MONITOR
K852076 · HGM
Ge Medical Systems Information...
Obstetrics & Gynecology · 53d
Cleared Jul 05, 1985
SICKLE-CHEX
K852107
Streck Laboratories, Inc.
Hematology · 51d
Cleared Jul 05, 1985
GLYCO-CHECK
K852111 · LCP
Thyroid Diagnostics, Inc.
Hematology · 51d
Cleared Jul 05, 1985
PRECINORM HB
K852136 · GGM
Boehringer Mannheim Corp.
Hematology · 50d
Cleared Jul 05, 1985
PULMONARY TEST SYSTEM FUDAC-30
K852307 · BZG
Futuremed Div. of Future Impex Corp.
Anesthesiology · 37d