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
70993–71016 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 09, 2003
AMPLATZER VASCULAR PLUG
K031810 · KRD
Aga Medical Corp.
Cardiovascular · 89d
Cleared Sep 09, 2003
SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX
K031849 · MHX
Datascope Corp.
Cardiovascular · 85d
Cleared Sep 09, 2003
INFINITY MEGACARE
K031970 · DQK
Siemens Medical Solutions USA, Inc.
Cardiovascular · 75d
Cleared Sep 09, 2003
AUDIT MICROCONTROLS MICROFD BNP CONTROL
K032122 · JJY
Aalto Scientific, Ltd.
Chemistry · 62d
Cleared Sep 09, 2003
RITA MODEL 1500X ELECTROSURGICAL RF GENERATOR
K032149 · GEI
Rita Medical Systems, Inc.
General & Plastic Surgery · 57d
Cleared Sep 09, 2003
COMP. E
K032179 · KLE
Parkell, Inc.
Dental · 57d
Cleared Sep 09, 2003
MEDLEY PCA MODULE, MODEL 8120
K032233 · MEA
Alaris Medical Systems, Inc.
General Hospital · 50d
Cleared Sep 09, 2003
TWISTER SUPERELASTIC LIGATING CLIP AND APPLIER
K032238 · FZP
Neurosel (Medical) Limited
General & Plastic Surgery · 50d
Cleared Sep 09, 2003
BLOOD PRESSURE MONITOR, MODEL KP-7000
K032492 · DXN
K-Jump Health Co., Ltd.
Cardiovascular · 28d
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