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
147793–147816 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 26, 1985
TISSUE EXPANDERS FOR RECONSTRUC-SURGERY 3600
K845036 · LCJ
Progress Mankind Technology
General & Plastic Surgery · 181d
Cleared Jun 26, 1985
ANSELL NO POWDER SURGEON'S GLOVES
K850635 · KGO
Ansell, Inc.
General Hospital · 127d
Cleared Jun 26, 1985
GUIDE, WIRE, ANGIOGRAPHIC
K850827 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE - MODIFICATION
K850828 · DQX
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
WIRE, GUIDE, CATHETER
K850829 · DQY
Lake Region Mfg., Inc.
Cardiovascular · 121d
Cleared Jun 26, 1985
ALBUMIN
K850931 · CIX
Dilab, Inc.
Chemistry · 111d
Cleared Jun 26, 1985
CARDIOSTAT 3 RECORDER
K851044 · DPS
Siemens Elema AB
Cardiovascular · 104d
Cleared Jun 26, 1985
SIRECUST 420 PATIENT DIALOG MONITOR
K851400 · DXJ
Siemens Medical Solutions USA, Inc.
Cardiovascular · 78d
Cleared Jun 26, 1985
SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE
K851626 · DSF
Eaton Medical Group
Cardiovascular · 69d
Cleared Jun 26, 1985
CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL
K851633 · DPS
Eaton Medical Group
Cardiovascular · 69d
Cleared Jun 26, 1985
HALL IRRIGATION SYSTEM
K852143 · GBX
Hall Surgical, Division of Zimmer, Inc.
General & Plastic Surgery · 41d
Cleared Jun 26, 1985
ACKRAD SIALOGRAPHY CATHETER
K852154
Ackrad Laboratories
General & Plastic Surgery · 40d
Cleared Jun 26, 1985
STRUNG NEURO SPONGE PATTIES, X-RAY OPAGUE
K852202 · EFQ
Ormed Mfg., Inc.
General & Plastic Surgery · 36d
Cleared Jun 26, 1985
SURE-COUNT 15 COUNT NEEDLE COUNTER
K852257
Kleen Test Products
General & Plastic Surgery · 33d
Cleared Jun 25, 1985
PHOTOMETER VARIOUS ONE FOR MICROTITERPLATES
K844894 · JJQ
Slt Labinstruments, Inc.
Chemistry · 190d
Cleared Jun 25, 1985
BHCG-ROCHE EIA
K850727 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 123d
Cleared Jun 25, 1985
G5 APPARATUS T, K1, K3 & THE PRESIDENT MODEL'S
K850851 · ISA
Physio Technology, Inc.
Physical Medicine · 116d
Cleared Jun 25, 1985
CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/
K850907 · JJT
Cala Diagnostics
Chemistry · 112d
Cleared Jun 25, 1985
CREATININE
K850932 · CGX
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
URIC ACID
K850933 · CDH
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
PHOSPHORUS
K850934 · CEO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
TOTAL PROTEINS
K850936 · CEK
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
CHOLESTEROL
K850938 · CGO
Dilab, Inc.
Chemistry · 110d
Cleared Jun 25, 1985
VENOUS RESERVOIR BAG BMR-1600
K851376 · DTN
American Bentley
Cardiovascular · 78d