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
78121–78144 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 2001
DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00
K010973 · JIL
Hypoguard USA, Inc.
Chemistry · 162d
Cleared Sep 11, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS...
K011045 · LYY
Shen Wei (Usa), Inc.
General Hospital · 159d
Cleared Sep 11, 2001
STERILE LATEX SURGICAL GLOVES (POWDERED) WITH PROTEIN CONTENT LABELING CLAIM...
K011066 · KGO
Smart Glove Corp. Sdn Bhd
General Hospital · 155d
Cleared Sep 11, 2001
HUANQIU AND SUPER (TWO BRANDS) STERILE ACUPUNCTURE NEEDLE FOR SINGLE USE
K011242 · MQX
Acusupply, Inc.
General Hospital · 141d
Cleared Sep 11, 2001
SURGIPLASTER CALCIUM SULFATE HEMIHYDRATE
K011403 · LYC
Orthogen Corp.
Dental · 127d
Cleared Sep 11, 2001
LATEX POWDER-FREE EXAMINATION GLOVES BLUE, POLYMER COATED, CONTAINS 50...
K011407 · LYY
Sempermed USA, Inc.
General Hospital · 145d
Cleared Sep 11, 2001
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
K011848 · FFK
Circon Video
Gastroenterology & Urology · 90d
Cleared Sep 11, 2001
ELEC-MATE E
K011926 · EBW
Nakanishi, Inc.
Dental · 83d
Cleared Sep 11, 2001
CHURCHILL MEDICAL SYSTEMS STOPCOCK
K012157 · FMG
Churchill Medical Systems, Inc.
General Hospital · 62d
Cleared Sep 11, 2001
STRATUS CS TROPONIN I CALIBRATOR
K012233 · JIT
Dade Behring, Inc.
Chemistry · 57d
Cleared Sep 11, 2001
CLEARFIL PHOTO CORE
K012705 · EBF
Kuraray Medical, Inc.
Dental · 28d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 614d
Cleared Sep 10, 2001
PALOMAR DERMALUX PULSED LIGHT SYSTEM
K010618 · GEX
Palomar
General & Plastic Surgery · 193d
Cleared Sep 10, 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR...
K011044 · LYY
Shen Wei (Usa), Inc.
General Hospital · 158d
Cleared Sep 10, 2001
KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR
K011841 · GCJ
Karl Storz Endoscopy
General & Plastic Surgery · 90d
Cleared Sep 10, 2001
PRESSURE ACTIVATED CHECK VALVE
K011888 · FPA
Churchill Medical Systems, Inc.
General Hospital · 84d
Cleared Sep 10, 2001
AVITA AGIL IT 101 INSTANT DIGITAL THERMOMETER
K012136 · FLL
Avita Corporation
General Hospital · 63d
Cleared Sep 10, 2001
CG-2211 SELFCHECK ECG TRANSMITTER
K012223 · DXH
Card Guard Scientific Survival , Ltd.
Cardiovascular · 56d
Cleared Sep 10, 2001
SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800,...
K012229 · FMT
National Custom Ent., Inc.
General Hospital · 56d
Cleared Sep 10, 2001
MODIFICATION TO CLEARFIL SE BOND
K012442 · KLE
Kuraray Medical, Inc.
Dental · 41d
Cleared Sep 10, 2001
CLEARFIL CORE NEW BOND
K012703 · EBF
Kuraray Medical, Inc.
Dental · 27d
Cleared Sep 10, 2001
CLEARFIL ST OPAQUER
K012704 · EBF
Kuraray Medical, Inc.
Dental · 27d
Cleared Sep 10, 2001
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · LJS
C.R. Bard, Inc.
General Hospital · 12d
Cleared Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
K010750 · GGN
Fisher Diagnostics
Hematology · 178d