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
70465–70488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 10, 2003
INTERA-SENSATION FAMILY
K031815 · LNH
Philips Medical Systems
Radiology · 90d
Cleared Sep 10, 2003
TSH RECEPTOR ANTIBODY (TRAB) COATED TUBE (CT) ASSAY KIT
K032134 · JZO
Kronus Market Development Associates,...
Immunology · 61d
Cleared Sep 10, 2003
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
K032271 · GEH
Wartner USA B.V.
General & Plastic Surgery · 49d
Cleared Sep 10, 2003
SIREMOBIL ISO-C 3D
K032280 · IZL
Siemens AG
Radiology · 48d
Cleared Sep 10, 2003
VITEK 2 GRAM POSITIVE MOXIFLOXACIN
K032399 · LON
bioMerieux, Inc.
Microbiology · 37d
Cleared Sep 10, 2003
SELDINGER SAFETY NEEDLE INTRODUCER
K032404 · DYB
Hdc Corp.
Cardiovascular · 37d
Cleared Sep 10, 2003
MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K032535 · DHR
Roche Diagnostics Corp.
Immunology · 23d
Cleared Sep 10, 2003
IP-XS COMPRESSION NAIL SYSTEM
K032548 · HSB
Plus Orthopedics
Orthopedic · 23d
Cleared Sep 10, 2003
MICRUS MICROCATHETER
K032624 · DQO
Micrus Corp.
Cardiovascular · 15d
Cleared Sep 09, 2003
PANDIN CONTINUOUS NERVE STIMULATING CATHETER, MODELS 561-18-05, 561-18-09,...
K022752 · CAZ
Hdc Corp.
Anesthesiology · 386d
Cleared Sep 09, 2003
ARABELLA NCPAP MASKS
K030563 · BZD
Hamilton Medical AG
Anesthesiology · 200d
Cleared Sep 09, 2003
AXIOM BIOLASER LLLT SERIES-1
K030622 · NHN
Axiom Usa., Inc.
Physical Medicine · 194d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGG ELISA
K030701 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
IMMULISA ANTI-BETA2 GLYCOPROTEIN I (B2GP1) IGM ELISA
K030702 · MSV
Immco Diagnostics, Inc.
Immunology · 187d
Cleared Sep 09, 2003
BLU-U, MODEL 4170
K031805 · GEX
Dusa Pharmaceuticals, Inc.
General & Plastic Surgery · 90d
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