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
85969–85992 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 22, 1999
AVIA PAIN MEDICATION DELIVERY SYSTEM
K990312 · MEA
Amtec Medical
General Hospital · 80d
Cleared Apr 22, 1999
ETEST FOR CEFUROXIME
K990722 · JWY
Ab Biodisk
Microbiology · 48d
Cleared Apr 22, 1999
BI-DIRECTIONAL TUNNELER
K991027 · DSY
Impra, Inc.
Cardiovascular · 24d
Cleared Apr 22, 1999
CAREVENT BLS, CAREVENT BLS+, CAREVENT ALS, CAREVENT ALS+, AND CAREVENT ATV
K991195 · BTL
O-Two Systems Intl., Inc.
Anesthesiology · 14d
Cleared Apr 21, 1999
COBE ARYLANE H1, H4, H6 & H9 HEMODIALYZERS/FILTERS
K982413 · KDI
Gambro Healthcare
Gastroenterology & Urology · 282d
Cleared Apr 21, 1999
ENSITE 3000 SYSTEM
K983456 · MTD
Endocardial Solutions, Inc.
Cardiovascular · 203d
Cleared Apr 21, 1999
THORAX FD AND MULTIX FD
K983732 · MQB
Siemens Medical Solutions USA, Inc.
Radiology · 181d
Cleared Apr 21, 1999
SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION
K984156 · JAK
Shimadzu Medical Systems
Radiology · 153d
Cleared Apr 21, 1999
PVS BASICS
K984436 · HQD
Paragon Vision Sciences
Ophthalmic · 128d
Cleared Apr 21, 1999
SHEATHES (NON-LATEX), STERILE
K990175 · ITX
Sheathing Technologies, Inc.
Radiology · 92d
Cleared Apr 21, 1999
SERIM BLOOD LEAK TEST STRIP
K990206 · FJD
Serim Research Corp.
Gastroenterology & Urology · 90d
Cleared Apr 21, 1999
PDQ AND PDQ-TI ABUTMENT
K990367 · DZE
Vident
Dental · 75d
Cleared Apr 21, 1999
DIABETIC NEEDLE DISPOSAL, MODEL # PMSM - 950
K990371 · FMI
Post Medical, Inc.
General Hospital · 72d
Cleared Apr 21, 1999
CANTOR & SILVER 5X TINTED (HIOXIFILCON A) SOFT (SPHERICAL & TORIC) DAILY WEAR...
K990757 · LPL
Cantor & Silver , Ltd.
Ophthalmic · 44d
Cleared Apr 21, 1999
URETERAL ACCESS SHEATH SET
K990775 · FED
Applied Medical Resources
Gastroenterology & Urology · 43d
Cleared Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
K990858 · GGN
Bio-Rad
Hematology · 37d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
K990915 · DHN
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 21, 1999
INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
K990916 · KTL
Stellar Bio Systems, Inc.
Immunology · 34d
Cleared Apr 21, 1999
S575 INTRAORAL DOCKING DENTAL CAMERA
K990948 · EIA
Sopro
Dental · 30d
Cleared Apr 20, 1999
QUICKDRAW VENOUS CANNULA
K981995 · DWF
Heartport, Inc.
Cardiovascular · 316d
Cleared Apr 20, 1999
EEG ELECTRODES MODEL 445 SERIES
K982053 · GXY
Class A Ent.
Neurology · 313d
Cleared Apr 20, 1999
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · JAQ
Nucletron Corp.
Radiology · 209d
Cleared Apr 20, 1999
PHOTOTHERAPY LAMP
K984589 · LBI
Medela, Inc.
General Hospital · 117d
Cleared Apr 20, 1999
ENDOMETRIAL SAMPLER
K990387 · HHK
U.A. Medical Products, Inc.
Obstetrics & Gynecology · 71d