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
154945–154968 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 21, 1983
AUTOIMMUNE TEST 1/2/3 SYSTEM
K833119 · DHN
Atlantic Antibodies
Immunology · 69d
Cleared Nov 21, 1983
TAGO DIFFU-GEN-APOLIPOPROTEIN B-100
K833129 · MSJ
Tago, Inc.
Immunology · 69d
Cleared Nov 21, 1983
INTRACATH INTRAVENOUS CATHETER UNIT
K833135 · FOZ
Parke-Davis Co.
General Hospital · 68d
Cleared Nov 21, 1983
ENZYME ANA TEST SYSTEM
K833148 · LJM
Immuno Concepts, Inc.
Immunology · 67d
Cleared Nov 21, 1983
ECG-GEL ELECTRODE GEL
K833172 · GYB
Whs Products, Inc.
Neurology · 66d
Cleared Nov 21, 1983
REGISTREX 1000 DIGITAL RADIOGRAPHY SYS
K833230 · JAA
Advanced Technology Laboratories, Inc.
Radiology · 89d
Cleared Nov 21, 1983
PORTA. X-RAY UNIT FP220 SCM-1-ETC,
K833239 · IZL
Showa X-Ray Co., Ltd.
Radiology · 91d
Cleared Nov 21, 1983
NUK BREAST SHIELD
K833450 · HFS
Reliance Products Corp.
General Hospital · 47d
Cleared Nov 21, 1983
CLEX
K833463 · KIS
Dextran Products, Ltd.
Hematology · 47d
Cleared Nov 21, 1983
C.B. RADIOLOGY DESIGN GONADSHIELD
K833523 · IWT
Radiology Design
Radiology · 62d
Cleared Nov 21, 1983
CEMAX-1000
K833525 · LMB
Contour Medical Systems, Inc.
Radiology · 60d
Cleared Nov 21, 1983
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · JAA
General Electric Co.
Radiology · 59d
Cleared Nov 21, 1983
HEARING AID, UNITRON UT1
K833614 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 21, 1983
HEARING AID UNITRON UI3
K833615 · ESD
Unitron Industries, Inc.
Ear, Nose, Throat · 39d
Cleared Nov 21, 1983
VENTRESCREEN BETA-HCG ENZYME IMMUNO
K833909 · ETD
Vxr, Inc.
Immunology · 7d
Cleared Nov 17, 1983
POCKET AID
K832702 · LDR
M.C. Johnson Co., Inc.
General Hospital · 98d
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMVIII W
K831781 · DXJ
Litton Medical Electronics
Cardiovascular · 167d
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMV 107
K831782 · DXJ
Litton Medical Electronics
Cardiovascular · 167d
Cleared Nov 16, 1983
SERVOMED BASIC BEDSIDE UNIT SMV 104
K831783 · DXJ
Litton Medical Electronics
Cardiovascular · 167d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 154-8/101
K832021 · DRT
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED SMC 108/111-426-24, 111-426
K832022 · DXJ
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED COMPACT MONITOR SMK 155-9
K832035 · DRT
Litton Medical Electronics
Cardiovascular · 146d
Cleared Nov 16, 1983
SERVOMED CENTRAL STATION SMV 206
K832131 · DRT
Litton Medical Electronics
Cardiovascular · 138d
Cleared Nov 15, 1983
ASAHI HOLLOW FIBER KIDNEYS, EXCEL
K833150 · KOC
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 61d