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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
141193–141216 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 09, 1987
MAXI-TAN DEVICE
K864546 · FTC
National Biological Corp.
General & Plastic Surgery · 51d
Cleared Jan 09, 1987
MOBIL 02
K864680 · BTI
Roman Laboratories, Inc.
Anesthesiology · 38d
Cleared Jan 09, 1987
CRESOLPHTHALEIN COMPLEXONE, CALCIUM
K864741 · CIC
Tech-Co, Inc.
Chemistry · 36d
Cleared Jan 09, 1987
WAKO(TM) AUTOKIT GPT
K864850 · CKA
Wako Chemicals USA, Inc.
Chemistry · 30d
Cleared Jan 09, 1987
SPECULUM, VAGINAL, METAL FIBEROPTIC
K864865 · HDG
Luxtec Corp.
Obstetrics & Gynecology · 29d
Cleared Jan 09, 1987
EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93
K864894 · DMT
Em Diagnostic Systems, Inc.
Toxicology · 25d
Cleared Jan 09, 1987
ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE
K864966 · CGF
Diagnostics Biochem Canada, Inc.
Chemistry · 18d
Cleared Jan 09, 1987
GENERAL PURPOSE CENTRIFUGE
K864974 · JQC
Norfolk Scientific, Inc.
Chemistry · 21d
Cleared Jan 09, 1987
LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II
K865014 · DGR
Bio-Rad
Immunology · 17d
Cleared Jan 08, 1987
EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95
K864553 · KLT
Em Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Jan 08, 1987
EASY-TEST QUINIDINE ITEM NO. 67---/95
K864607 · LBZ
Em Diagnostic Systems, Inc.
Toxicology · 45d
Cleared Jan 08, 1987
MODEL FORCE 4B ELECTROSURGICAL GENERATOR
K864675 · GEI
Valleylab, Inc.
General & Plastic Surgery · 37d
Cleared Jan 08, 1987
AMOENA BREAST FORMS
K864785 · GBI
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
PERSONALLY(TM), MODEL 241 SIZES 0-12,LEFT & RIGHT
K864786 · GBI
Coloplast Corp.
General & Plastic Surgery · 31d
Cleared Jan 08, 1987
CK 5000 SERIES, ACE BANDAGE/ESMARK BANDAGE
K864816
Currie Medical Specialties, Inc.
General & Plastic Surgery · 30d
Cleared Jan 08, 1987
MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
K864851 · GEI
Valleylab, Inc.
General & Plastic Surgery · 29d
Cleared Jan 07, 1987
VNA OPTICAL CORRELATOR
K861514 · LLZ
Vna Systems, Inc.
Radiology · 259d
Cleared Jan 07, 1987
ARTHROPHONOMETER
K862286 · NFQ
Arthrotek, Inc.
Dental · 205d
Cleared Jan 07, 1987
FYODOROV COLLAGEN CORNEAL SHIELD
K862315 · MOE
Medical Technology Development Corp.
Ophthalmic · 203d
Cleared Jan 07, 1987
EZ-SCREEN: CANNABINOID
K862916 · KLT
Environmental Diagnostics, Inc.
Toxicology · 159d
Cleared Jan 07, 1987
THE OB-GYN CONCEPTS VAGINAL ASPIRATOR
K863610 · KOH
Ob/Gyn Concepts, Ltd.
Obstetrics & Gynecology · 113d
Cleared Jan 07, 1987
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
K863918 · DQA
Marquest Medical Products, Inc.
Anesthesiology · 91d
Cleared Jan 07, 1987
MICRO-VENT
K864321 · DZE
Core-Vent Corp.
Dental · 65d
Cleared Jan 07, 1987
REMBRANDT PORCELAIN TINTING KIT
K864346 · EBF
Den-Mat Corp.
Dental · 64d