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
77329–77352 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 30, 2001
IUI, MODEL 4220
K013501 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 39d
Cleared Nov 30, 2001
EMTRAC
K013536 · MQF
Gynetics Medical Products NV
Obstetrics & Gynecology · 38d
Cleared Nov 29, 2001
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS)
K001121 · CBF
Engineered Medical Technology, Inc.
Anesthesiology · 601d
Cleared Nov 29, 2001
MULTISTIM
K011308 · BXN
Pajunk GmbH
Anesthesiology · 213d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C4 TEST SYSTEM
K012359 · DBI
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
TINA-QUANT COMPLEMENT C3C TEST SYSTEM
K012361 · CZW
Roche Diagnostics Corp.
Immunology · 127d
Cleared Nov 29, 2001
DRYSTAR, MODEL 4500M
K012941 · LMC
Agfa Corp.
Radiology · 90d
Cleared Nov 29, 2001
NEPTUNE WASTE MANAGEMENT STSTEM
K012991 · FYD
Stryker Instruments
General Hospital · 84d
Cleared Nov 29, 2001
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE
K013049 · LRK
Dennis R. Bailey, Dds
Dental · 79d
Cleared Nov 29, 2001
RESECTION ABLATOR
K013117 · HRX
Linvatec Corp.
Orthopedic · 72d
Cleared Nov 29, 2001
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE
K013261 · LZA
Shanghai Motex Healthcare Co., Ltd.
General Hospital · 59d
Cleared Nov 29, 2001
MICRO STAMPING LIGATING CLIP
K013264 · FZP
Micro Stamping Corp.
General & Plastic Surgery · 59d
Cleared Nov 29, 2001
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN...
K013324 · KGO
Tillotson Healthcare Corp.
General Hospital · 55d
Cleared Nov 29, 2001
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR,...
K013427 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 44d
Cleared Nov 29, 2001
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM
K013432 · KTL
Immuno Concepts, Inc.
Immunology · 45d
Cleared Nov 29, 2001
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS...
K013443 · LYY
Maxter Glove Manufacturing Sdn Bhd
General Hospital · 43d
Cleared Nov 29, 2001
KP + LFM
K013489 · BZH
Pds Healthcare Products, Inc.
Anesthesiology · 38d
Cleared Nov 29, 2001
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE
K013845 · CCK
Oridion Medical 1987 , Ltd.
Anesthesiology · 9d
Cleared Nov 28, 2001
DISPOSABLE STORAGE CAP
K010366 · FJI
Molded Products, Inc.
Gastroenterology & Urology · 294d
Cleared Nov 28, 2001
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001
K010607 · LJH
Benlan, Inc.
Gastroenterology & Urology · 272d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 162d
Cleared Nov 28, 2001
BIOPLATE RESORBABLE BONE SCREW
K012908 · DZL
Bioplate, Inc.
Dental · 90d
Cleared Nov 28, 2001
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B
K012917 · HFW
Dynarex Corp.
Obstetrics & Gynecology · 90d
Cleared Nov 28, 2001
MOLDED CRANIAL HELMET
K012920 · MVA
Fairview Orthopedic Laboratory
Neurology · 90d