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
76825–76848 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Nov 28, 2001
TCM ENDO III
K013185 · EFA
NOUVAG AG
Dental · 65d
Cleared Nov 28, 2001
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL...
K013199 · MHX
Philips Medical Systems, Inc.
Cardiovascular · 64d
Cleared Nov 28, 2001
TOTAL O2
K013472 · CAW
Chad Therapeutics, Inc.
Anesthesiology · 41d
Cleared Nov 28, 2001
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
K013581 · DQY
Cordis, A Johnson & Johnson Co.
Cardiovascular · 30d
Cleared Nov 28, 2001
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM
K013682 · DZE
Basic Dental Implant Systems, Inc.
Dental · 21d
Cleared Nov 28, 2001
SILMED NASAL SEPTAL BUTTON
K013696 · LFB
Silmed, Inc.
Ear, Nose, Throat · 21d
Cleared Nov 27, 2001
PERIOLASE ND:YAG DENTAL LASER SYSTEM
K010771 · GEX
Millennium Dental Technologies, Inc.
General & Plastic Surgery · 258d
Cleared Nov 27, 2001
ORALLITE COMPREHENSIVE EXAM TRAY
K012070 · MPU
Trylon Corp.
Obstetrics & Gynecology · 148d
Cleared Nov 27, 2001
EBI SPINELINK - II SPINAL FIXATION SYSTEM
K012516 · KWP
Ebi, L.P.
Orthopedic · 113d