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
73057–73080 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
K030144 · GKZ
Abx Diagnostics
Hematology · 16d
Cleared Jan 31, 2003
SETPOINT CHEMISTRY CALIBRATOR
K030169 · JIX
Bayer Healthcare, LLC
Chemistry · 14d
Cleared Jan 30, 2003
AECP-A, AUTOMATIC EXTERNAL COUNTERPULSATION DEVICE
K021340 · DRN
External Counterpulsation Lab
Cardiovascular · 279d
Cleared Jan 30, 2003
TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS
K022221 · MPB
Deltec, Inc.
Gastroenterology & Urology · 205d
Cleared Jan 30, 2003
LEMAITRE VASCULAR DISPOSABLE VEIN STRIPPER
K023688 · GAF
LeMaitre Vascular, Inc.
General & Plastic Surgery · 90d
Cleared Jan 30, 2003
ANGIONEW-IV
K023701 · DRN
Living Data Technologies Corporation
Cardiovascular · 87d
Cleared Jan 30, 2003
BI-OSTETIC
K023703 · MQV
Berkeley Advanced Biomaterials, Inc.
Orthopedic · 87d
Cleared Jan 30, 2003
KSEA SCB ACC CONTROL
K023704 · FTA
KARL STORZ Endoscopy-America, Inc.
General & Plastic Surgery · 87d
Cleared Jan 30, 2003
GRADIA DIRECT
K023814 · EBF
GC America, Inc.
Dental · 76d
Cleared Jan 30, 2003
ACROSEAL ROOT CANAL OR APICAL SEALER
K023976 · KIF
Septodont S.A.S.
Dental · 64d
Cleared Jan 30, 2003
BAYER ADVIA CENTAUR HER-2/NEU ASSAY
K024017 · NCW
Bayer Corp.
Immunology · 57d
Cleared Jan 29, 2003
CARDIMA ABLATION SYSTEM
K022008 · OCL
Cardima, Inc.
Cardiovascular · 224d
Cleared Jan 29, 2003
MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA
K022807 · GEX
Creative Technologies, Inc.
General & Plastic Surgery · 159d
Cleared Jan 29, 2003
SAS RSV TEST
K022845 · GQG
Sa Scientific, Inc.
Microbiology · 155d
Cleared Jan 29, 2003
1-CCD ENDOCAM 5520 SYSTEM
K023659 · FET
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Jan 29, 2003
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · LIB
Osmetech
Microbiology · 89d
Cleared Jan 29, 2003
AURORA MR-GUIDED INTERVENTIONAL SYSTEM
K023686 · LNH
Aurora Imaging Technology, Inc.
Radiology · 89d
Cleared Jan 29, 2003
BICON TRANSITIONAL IMPLANT (BTI) SYSTEM
K023705 · DZE
Bicon, Inc.
Dental · 86d
Cleared Jan 29, 2003
DEVEX MESH SYSTEM
K023835 · MQP
Depuyacromed
Orthopedic · 72d
Cleared Jan 29, 2003
MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086
K030049 · GEI
Rubicor Medical, Inc.
General & Plastic Surgery · 23d
Cleared Jan 29, 2003
TERASON MODEL 2000/BAS PORTABLE ULTRASOUND SYSTEM
K030191 · IYN
Teratech Corp.
Radiology · 8d
Cleared Jan 29, 2003
APEX 90
K030206 · EJT
We Dong Myung Dental Industrial Co.,...
Dental · 8d
Cleared Jan 28, 2003
BIOSORB RESORBABLE VOID FILLER
K021963 · MQV
Sciences ET Bio Materiaux (Sbm)
Orthopedic · 228d
Cleared Jan 28, 2003
SW-180 SHORTWAVE THERAPY UNIT
K022846 · IMJ
Ito Co., Ltd.
Physical Medicine · 154d