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
71017–71040 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 2003
ENDOSCOPIC APPLICATOR
K031882 · GCJ
Baxter Healthcare Corp
General & Plastic Surgery · 79d
Cleared Sep 05, 2003
GEL MARK III BIOPSY SITE MARKER
K031938 · NEU
Senorx, Inc.
General & Plastic Surgery · 74d
Cleared Sep 05, 2003
BPCARD
K031964 · DXN
Qrs Diagnostic, LLC
Cardiovascular · 72d
Cleared Sep 05, 2003
SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE
K031973 · LXT
Synthes (Usa)
Orthopedic · 71d
Cleared Sep 05, 2003
CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)
K032027 · CIS
Cholestech Corp.
Chemistry · 66d
Cleared Sep 05, 2003
PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601
K032038 · DQK
Quinton, Inc.
Cardiovascular · 66d
Cleared Sep 05, 2003
CARESTART-PREGNANCY AND CARESTART PLUS-PREGNANCY
K032159 · LCX
Access Bio Incorporate
Chemistry · 52d
Cleared Sep 05, 2003
N/T PROTEIN CONTROL
K032237 · JJY
Dade Behring, Inc.
Immunology · 46d
Cleared Sep 05, 2003
BENZODIAZEPINE ENZYME IMMUNOASSAY
K032365 · JXM
Lin-Zhi International, Inc.
Toxicology · 36d
Cleared Sep 05, 2003
ACUEITY MEDICAL LIGHT SOURCE
K032430 · FCW
Acueity, Inc.
Gastroenterology & Urology · 30d
Cleared Sep 05, 2003
PVS 1700 STEERABLE DELIVERY SYSTEM MICROCATHETER
K032494 · KRA
Precision Vascular Systems, Inc.
Cardiovascular · 23d
Cleared Sep 05, 2003
INTERLOK BIO-MODULAR HUMERAL STEMS
K032507 · KWT
Biomet, Inc.
Orthopedic · 22d
Cleared Sep 05, 2003
ENCLOSE II ANASTOMOSIS ASSIST DEVICE
K032589 · DXC
Novare Surgical Systems, Inc.
Cardiovascular · 14d
Cleared Sep 05, 2003
ONE DIMENSIONAL WATER PHANTOM, WP 1D
K032594 · IYE
Wellhofer Dosimetrie
Radiology · 14d
Cleared Sep 04, 2003
DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER
K030629 · DQA
Dolphin Medical, Inc.
Anesthesiology · 189d
Cleared Sep 04, 2003
TMC ELECTRICAL SCOOTER, EASY 405
K031313 · INI
Tmc Technology Corp.
Physical Medicine · 133d
Cleared Sep 04, 2003
TMC ELECTRICAL SCOOTER, EASY 411
K031314 · INI
Tmc Technology Corp.
Physical Medicine · 133d
Cleared Sep 04, 2003
TMC ELECTRICAL SCOOTER, EASY 321
K031315 · INI
Tmc Technology Corp.
Physical Medicine · 133d
Cleared Sep 04, 2003
MACROPORE CARDIO-WRAP (TS)
K031785 · OMH
Macropore Biosurgery, Inc.
Cardiovascular · 86d
Cleared Sep 04, 2003
PIT & FISSURE SEALANT WITH FLUORIDE
K031811 · EBC
Harry J. Bosworth Co.
Dental · 84d
Cleared Sep 04, 2003
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY
K031857 · DEM
Bayer Diagnostics Corp.
Chemistry · 80d
Cleared Sep 04, 2003
EBI XFIX DFS SYSTEM
K031919 · KTT
Ebi, L.P.
Orthopedic · 73d
Cleared Sep 04, 2003
ALANTECH GRAFT FIXATION SCREW
K031937 · HWC
Arthrocare Corp.
Orthopedic · 73d
Cleared Sep 04, 2003
SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES
K032032 · HRS
Synthes (Usa)
Orthopedic · 65d