FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
92665–92688 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1997
OPUS S MODEL 4121 AND 4124 PACEMAKERS
K970072 · DXY
Ela Medical, Inc.
Cardiovascular · 233d
Cleared Aug 29, 1997
ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER
K970296 · MCW
Boston Scientific Corp
Cardiovascular · 214d
Cleared Aug 29, 1997
MPC (MODEL 7000) EXTERNAL TEMPORARY PACEMAKER SYSTEM
K970347 · DTE
Paladin Medical, Inc.
Cardiovascular · 214d
Cleared Aug 29, 1997
AMBIDERM
K971102 · LYY
Supertex Industrial, S.A. DE C.V.
General Hospital · 156d
Cleared Aug 29, 1997
W.A.
K971200 · LYY
W.A. Rubbermate Co., Ltd.
General Hospital · 150d
Cleared Aug 29, 1997
CRYO CHECK INR VALIDATION SET
K971219 · GGN
Precision Biologicals, Inc.
Hematology · 149d
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · GKL
Bayer Corp.
Hematology · 91d
Cleared Aug 29, 1997
SPOROX TEST STRIPS
K972035 · JOJ
Serim Research Corp.
General Hospital · 88d
Cleared Aug 29, 1997
MSI MAGNA-STYM
K972055 · IPF
Microvas Systems, Inc.
Physical Medicine · 88d
Cleared Aug 29, 1997
AMS FOREIGN BODY EXTRATOR
K972091 · FFL
American Medical Systems, Inc.
Gastroenterology & Urology · 86d
Cleared Aug 29, 1997
VOLKER HOSPITAL BED, MODEL K960
K972115 · FNL
Volker Healthcare, Inc.
General Hospital · 85d
Cleared Aug 29, 1997
DREAM CATCHER
K972122 · GXY
Rest Technologies, Inc.
Neurology · 85d
Cleared Aug 29, 1997
SHARPS SHUTTLE
K972279 · FMI
Sage Products, Inc.
General Hospital · 72d
Cleared Aug 29, 1997
3M AURORA SYSTEM
K972355 · EBZ
3M Company
Dental · 65d
Cleared Aug 29, 1997
BTI CORTICAL BONE SCREWS
K972403 · HWC
Biodynamic Technologies, Inc.
Orthopedic · 64d
Cleared Aug 29, 1997
LINK CEMENT PLUG
K972411 · LZN
Turnkey Intergration USA, Inc.
Orthopedic · 64d
Cleared Aug 29, 1997
FRESHCELLS
K972414 · KIR
Diagnostic Hybrids, Inc.
Microbiology · 63d
Cleared Aug 29, 1997
EASY BOND
K972421 · KLE
Parkell, Inc.
Dental · 63d
Cleared Aug 29, 1997
URESIL GENERAL PURPOSE DRAINAGE CATHETER, URESIL NEPHROSTOMY CATHETER, URESIL...
K972583 · FGE
Uresil Corp.
Gastroenterology & Urology · 50d
Cleared Aug 29, 1997
AIA-PACK TSH 3RD-GEN ASSAY
K972586 · JLW
Tosoh Medics, Inc.
Chemistry · 49d
Cleared Aug 29, 1997
PREGNACOL PREGNANCY TEST
K972606 · JHJ
Immunostics Inc.,
Chemistry · 49d
Cleared Aug 29, 1997
QUICKVUE ONE-STEP HCG-URINE
K972742 · JHI
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDS Q.S. HCG-URINE
K972748 · JHI
Quidel Corp.
Chemistry · 37d
Cleared Aug 29, 1997
CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
K972976 · JJT
More Diagnostics
Chemistry · 18d