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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
92161–92184 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 28, 1997
COMSAT ADULT,PEDIATRIC,INFANT,NEONATAL,DISPOSABLE SENSOR/COMSAT REUSABLE...
K970769 · DQA
Aristo Medical
Anesthesiology · 178d
Cleared Aug 28, 1997
FEMALE EXTERNAL URINARY COLLECTION POUCH
K971499 · EXI
Mediquest, Inc.
Gastroenterology & Urology · 125d
Cleared Aug 28, 1997
QUIKPAC II ONE STEP COCAINE TEST
K972059 · DIO
Drial Consultants, Inc.
Toxicology · 87d
Cleared Aug 28, 1997
INFUSASLEEVE IIA (IS-2A)
K972175 · QEY
Localmed, Inc.
Cardiovascular · 80d
Cleared Aug 28, 1997
REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN
K972359 · JSO
Remel, L.P.
Microbiology · 64d
Cleared Aug 28, 1997
AG CHEMISTRY ANALYZER SYSTEM
K972409 · JJG
Landmark Scientific, Inc.
Chemistry · 63d
Cleared Aug 28, 1997
SODIUM CHLORIDE INHALATION SOLUTION, USP
K972466 · CAF
Holopack International, LP
Anesthesiology · 58d
Cleared Aug 28, 1997
STERILE WATER FOR INHALATION, USP
K972467 · CAF
Holopack International, LP
Anesthesiology · 58d
Cleared Aug 28, 1997
RAICHEM PREALBUMIN SPIA
K972812 · DDS
Hemagen Diagnostics, Inc.
Immunology · 31d