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
94273–94296 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 21, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT
K965033 · MGA
Beckman Instruments, Inc.
Immunology · 125d
Cleared Apr 21, 1997
SOLO-SLED
K970090 · IXA
Solo-Sled, LLC
Radiology · 101d
Cleared Apr 21, 1997
GSI CANNULA WITH INTRODUCER
K970201 · DYB
General Surgical Innovations
Cardiovascular · 90d
Cleared Apr 21, 1997
VITALLIUM 2000 ALLOY
K970205 · EJH
Austenal, Inc.
Dental · 90d
Cleared Apr 21, 1997
ARTOS, DIPLOS SYSTEM
K970284 · KWY
Turnkey Intergration USA, Inc.
Orthopedic · 87d
Cleared Apr 21, 1997
SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
K970314 · MSJ
Beckman Instruments, Inc.
Chemistry · 87d
Cleared Apr 21, 1997
ULTRACELL NEURO SPONGES
K970328 · HBA
Ultracell Medical Technologies, Inc.
Neurology · 84d
Cleared Apr 21, 1997
ACUFEX DOUBLE ARMED SUTURE NEEDLE
K970416 · GAT
Smith & Nephew Endoscopy, Inc.
General & Plastic Surgery · 76d
Cleared Apr 21, 1997
RIGHT ANGLE LASER FIBERS
K970422 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 77d
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