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
70489–70512 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2003
BAYER ADVIA CENTAUR AUTOMATED CHEMILUMINESCENCE ANALYZER
K032525 · NBC
Bayer Healthcare, LLC
Chemistry · 25d
Cleared Sep 09, 2003
BD ECLIPSE BIFURCATED NEEDLE
K032528 · SCL
Becton, Dickinson & CO
General Hospital · 25d
Cleared Sep 09, 2003
TRIUMPH VTX WITH LIFEVALVE CATHETER
K032557 · LJT
Horizon Medical Products, Inc.
General Hospital · 21d
Cleared Sep 09, 2003
VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233
K032600 · LJT
Boston Scientific Corp
General Hospital · 15d
Cleared Sep 08, 2003
MARQUETTE HUBER TRAP SAFETY INFUSION SET
K021471 · FPA
Marquette Medical, Inc.
General Hospital · 488d
Cleared Sep 08, 2003
I-STAT KAOLIN ACT TEST
K023582 · JBP
I-Stat Corporation
Hematology · 319d
Cleared Sep 08, 2003
SYNTHETIC (WHITE) VINYL PATIENT EXAMINATION GLOVES-POWDER FREE
K031108 · LYZ
Shijiazhuang Great Vision Plastic...
General Hospital · 153d
Cleared Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540....
K031377 · GKP
Dade Behring, Inc.
Hematology · 130d
Cleared Sep 08, 2003
DURASIS DURAL SUBSTITUTE
K031850 · GXQ
Cook Biotech, Inc.
Neurology · 84d
Cleared Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED...
K032039 · GKZ
Sysmex America, Inc.
Hematology · 69d
Cleared Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
K032524 · GKZ
Bayer Healthcare, LLC
Hematology · 24d
Cleared Sep 08, 2003
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K032549 · LZA
Matang Mfg. Sdn. Bhd.
General Hospital · 21d
Cleared Sep 05, 2003
COMPRESSOR MINI, 115 V, MODEL 64 81 779 EH81E
K023354 · BTI
Siemens Elema AB
Anesthesiology · 333d
Cleared Sep 05, 2003
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES
K031764 · IYE
Siemens Medical Solutions USA, Inc.
Radiology · 88d
Cleared Sep 05, 2003
TI FENESTRATED PLATE
K031772 · KWP
Interpore Cross Intl.
Orthopedic · 88d
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