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
93769–93792 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1997
SMARTSITE ACCESS PIN
K970485 · FPA
Ivac Medical Systems
General Hospital · 70d
Cleared Apr 21, 1997
EVT MARKER BOARD
K970608 · JAA
Guidant Cardiac and Vascular Surgery
Radiology · 62d
Cleared Apr 21, 1997
MINI SAMPLER PROCESSOR
K970616 · JQW
Cavro Scientific Instruments, Inc.
Chemistry · 62d
Cleared Apr 21, 1997
CT-MODELLER SYSTEM
K970617 · LLZ
Materialise NV
Radiology · 62d
Cleared Apr 21, 1997
SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS
K970734 · OWB
Siemens Medical Solutions USA, Inc.
Radiology · 52d
Cleared Apr 21, 1997
INNERDYNE STEP TROCAR EXPANABLE PORT, OPEN STEP
K970754 · GCJ
Innerdyne, Inc.
General & Plastic Surgery · 49d
Cleared Apr 21, 1997
LIQUID GLUCOSE (OXIDASE) REAGENT SET
K970781 · CGA
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Apr 21, 1997
URIC ACID REAGENT
K970867 · KNK
Derma Media Lab., Inc.
Chemistry · 42d
Cleared Apr 21, 1997
BTI DISTAL FEMORAL INTRAMEDULLARY ROD SYSTEM
K970897 · HSB
Biodynamic Technologies, Inc.
Orthopedic · 41d
Cleared Apr 21, 1997
WAKO TOTAL BILIRUBIN V
K970985 · JFM
Wako Chemicals USA, Inc.
Chemistry · 34d
Cleared Apr 21, 1997
TRIGLYCERIDES
K971005 · JGY
Derma Media Lab., Inc.
Chemistry · 33d
Cleared Apr 21, 1997
IMAGYN EXPANDABLE LAPAROSCOPIC INTRODUCER
K971255 · HET
Imagyn Medical, Inc.
Obstetrics & Gynecology · 17d
Cleared Apr 21, 1997
ALT OR SGPT
K971323 · CKA
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Apr 21, 1997
AST OR SGOT
K971344 · CIT
Carolina Liquid Chemistries Corp.
Chemistry · 11d
Cleared Apr 21, 1997
SYNCHRON CX SYSTEMS PHOSPHORUS REAGENT
K971363 · CEO
Carolina Liquid Chemistries Corp.
Chemistry · 14d
Cleared Apr 18, 1997
GAMBRO POLYFLUX 14, 17, & 21 HEMODIALYZERS
K955487 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 504d
Cleared Apr 18, 1997
MODEL AMI INFANT CENTRAL APHEA/HEART RATE MONITOR
K961972 · BZQ
Aequitron Medical, Inc.
Anesthesiology · 333d
Cleared Apr 18, 1997
QUARTET CLINICAL SYSTEM
K963761 · BZD
Respironics, Inc.
Anesthesiology · 212d
Cleared Apr 18, 1997
QFC UMBILICAL CLAMP
K963889 · HFW
Qfc Industries
Obstetrics & Gynecology · 204d
Cleared Apr 18, 1997
CAPNOCHECK PLUS
K970209 · CCK
Bci Intl., Inc.
Anesthesiology · 87d
Cleared Apr 18, 1997
POWERED TOOTHBRUSH
K970381 · JEQ
Emjoi Action USA, Ltd.
Dental · 74d
Cleared Apr 17, 1997
ALEXANDER BOX, BATTERY, RECHARGEABLE
K963305 · BWA
Alexander Mfg. Co.
Cardiovascular · 238d
Cleared Apr 17, 1997
RESPOSABLE OMNI TIP(TM) SWITCHABLE TIPS (MULTIPLE)
K964585 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 153d
Cleared Apr 17, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
K965035 · JIQ
Beckman Instruments, Inc.
Immunology · 121d