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
169057–169080 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 22, 1979
CK-NUC REAGENT
K790916 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
SPIN CHEM CK-NAC REAGENT
K790917 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
ESKLAB REAGENT TABLETS
K790918 · JHS
Smithkline Diagnostics, Inc.
Chemistry · 39d
Cleared Jun 22, 1979
MI-MARK ENDOCERVICAL SAMPLING SET
K790923 · KNA
Simpson/Basye, Inc.
Obstetrics & Gynecology · 38d
Cleared Jun 22, 1979
TRACHE FITTING M-307
K790930 · BTO
Mem Medical, Inc.
Anesthesiology · 38d
Cleared Jun 22, 1979
TRISEDTA-BORATE ELECTROPHORESIS FILM AGA
K790943 · GHS
Corning Medical & Scientific
Hematology · 35d
Cleared Jun 22, 1979
ZIMMER R TOTAL SHOULDER II
K790987 · KWT
Zimmer, Inc.
Orthopedic · 28d
Cleared Jun 22, 1979
YEAST-PALETTE TM
K790991 · JXB
Micro-Palettes, Inc.
Microbiology · 24d
Cleared Jun 22, 1979
PSEUDO-PALETTE TM
K790992 · JSW
Micro-Palettes, Inc.
Microbiology · 24d
Cleared Jun 22, 1979
APOLLO HEART RATE INDICATOR
K790999 · JOM
Apollo Products, Inc.
Cardiovascular · 24d
Cleared Jun 22, 1979
PENLIGHT/SWAB HOLDER
K791001 · KYT
Concept, Inc.
General Hospital · 24d
Cleared Jun 22, 1979
4F STERILE BALLOON-LESS, CATHETER 913-28
K791026 · KRB
Waters Assoc., Inc.
Cardiovascular · 18d
Cleared Jun 22, 1979
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
K791030 · JPK
Beckman Instruments, Inc.
Hematology · 18d
Cleared Jun 22, 1979
SINGLE-USE MINI-BULLDOG
K791098 · DXC
Med General
Cardiovascular · 10d
Cleared Jun 22, 1979
STOPCOCK, THREE WAY
K791107 · DTL
Norton Performance Plastics Corp.
Cardiovascular · 8d
Cleared Jun 21, 1979
COLOSTOMY DEVICE, MACLET MAGNETIC
K782154
Maclet Medical Devices, Inc.
General & Plastic Surgery · 181d
Cleared Jun 20, 1979
RDI-1 HOLLOW FIBER DIALYZER
K790696 · FJI
Renal Devices, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 20, 1979
HABITSABATER
K790738 · HCB
Jackson Ent.
Neurology · 65d
Cleared Jun 20, 1979
HEEL GARD
K790954 · FRK
Fem-Gard, Inc.
General Hospital · 29d
Cleared Jun 20, 1979
COVER GARD
K790955 · FRK
Fem-Gard, Inc.
General Hospital · 29d
Cleared Jun 20, 1979
MIC-2000 QUAD INOCULUM TRAY
K790971 · JTC
Dynatech Laboratories, Inc.
Microbiology · 29d
Cleared Jun 20, 1979
MIC-2000 INOCULATOR TEMPLATE
K790974 · JTC
Dynatech Laboratories, Inc.
Microbiology · 28d
Cleared Jun 20, 1979
CAST BRACE COMPONENTS
K791057 · IQI
3M Company
Physical Medicine · 12d
Cleared Jun 20, 1979
BOUNDARY SPECIALTY GOWN
K791062 · FYA
Procter & Gamble Mfg. Co.
General Hospital · 12d