Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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176,076 results
71593–71616 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
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