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
71641–71664 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 07, 2003
FOTONA FIDELIS PLUS ND:YAG LASER SYSTEM
K024204 · GEX
Fotona D.D.
General & Plastic Surgery · 199d
Cleared Jul 07, 2003
PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM
K030076 · JKA
Biomed Personal Metabolic and...
Chemistry · 180d
Cleared Jul 07, 2003
VENTLAB BACTERIAL FILTER, MODEL BF100
K030271 · CAH
Ventlab Corp.
General Hospital · 161d
Cleared Jul 07, 2003
NXSTAGE SYSTEM ONE
K030470 · FII
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Jul 07, 2003
ITI DENTAL IMPLANT SYSTEM
K031055 · DZE
Straumann USA
Dental · 95d
Cleared Jul 07, 2003
REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001
K031208 · MSV
Corgenix, Inc.
Immunology · 81d
Cleared Jul 07, 2003
MODEL 780
K031383 · BTT
Hudson Respiratory Care, Inc.
Anesthesiology · 67d
Cleared Jul 07, 2003
MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K031777 · FGE
Cordis Corp.
Gastroenterology & Urology · 27d
Cleared Jul 07, 2003
DIGITAL CLINICAL THERMOMETER, MODELS ACT2130, ACT 2230, ACT 2330, ACT 3136,...
K031905 · FLL
Actherm, Inc.
General Hospital · 17d
Cleared Jul 03, 2003
EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY...
K024303 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 191d
Cleared Jul 03, 2003
GENERAL SEMEN ANALYSIS (GSA) KIT
K024337 · POV
Bioshaf , Ltd.
Hematology · 188d
Cleared Jul 03, 2003
FASTPACK FREE T4 IMMUNOASSAY
K030329 · CEC
Qualigen, Inc.
Chemistry · 153d
Cleared Jul 03, 2003
SISS, INC. (D.B.A.MEDISISS) REPROCESSD ELECTROSURGICAL INSTRUMENTS AND...
K030919 · NLR
Medisiss
Gastroenterology & Urology · 101d
Cleared Jul 03, 2003
CARBON FIBER BRIDGE, MODEL 28757
K031070 · EBI
Nobel Biocare AB
Dental · 90d
Cleared Jul 03, 2003
SURGRX ENSEAL VESSEL SEALING AND HEMOSTASIS SYSTEM INCLUDING THE ENSEAL...
K031133 · GEI
Surgrx, Inc.
General & Plastic Surgery · 85d
Cleared Jul 03, 2003
SOFT (HYDROPHILIC) CONTACT LENS CARE SOLUTION
K031193 · LPN
Alcon, Inc.
Ophthalmic · 78d
Cleared Jul 03, 2003
PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS...
K031422 · DPS
Philips Medical Systems
Cardiovascular · 58d
Cleared Jul 03, 2003
STAND OUT
K031484 · ELW
Kerr Corp.
Dental · 52d
Cleared Jul 03, 2003
MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES
K031623 · FZP
Coalescent Surgical
General & Plastic Surgery · 41d
Cleared Jul 03, 2003
ACCU-CHEK COMPACT TEST STRIP
K031755 · LFR
Roche Diagnostics Corp.
Chemistry · 27d
Cleared Jul 03, 2003
MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM
K031843 · NBW
Medline Industries, Inc.
Chemistry · 17d
Cleared Jul 02, 2003
READI-STRAND, MODEL PSSTRAND
K023179 · KXK
Worldwide Medical Technologies, LLC
Radiology · 281d
Cleared Jul 02, 2003
SECQUIRE CELL SEPARATOR
K024080 · JQC
Perfusion Partners & Assoc., Inc.
Hematology · 204d
Cleared Jul 02, 2003
S7 ELITE AND AUTOSET SPIRIT CPAP SYSTEMS WITH RESLINK
K024191 · BZD
Resmed, Ltd.
Anesthesiology · 194d