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
85969–85992 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1999
DIMENSION BITE
K991008 · ELW
Espe Dental AG
Dental · 84d
Cleared Jun 18, 1999
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
K991047 · LTZ
Hardcover Products, Inc.
Obstetrics & Gynecology · 80d
Cleared Jun 18, 1999
NORMA 10
K991243 · LNH
Odin Technologies , Ltd.
Radiology · 67d
Cleared Jun 18, 1999
EXPLOR-X 70
K991310 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 63d
Cleared Jun 18, 1999
CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS
K991318 · KPS
Hitachi Medical Corp. of America
Radiology · 60d
Cleared Jun 18, 1999
PANATOME
K991518 · EHD
Imaging Sciences Intl., Inc.
Radiology · 49d
Cleared Jun 18, 1999
HDI 5000 DIAGNOSTIC ULTRASOUND SYSTEM
K991671 · IYO
Advanced Technology Laboratories, Inc.
Radiology · 32d
Cleared Jun 18, 1999
CHIRON DIAGNOSTICS ACS: 180 FT3
K991692 · CDP
Chiron Diagnostics Corp.
Chemistry · 31d
Cleared Jun 18, 1999
HISPEED NX/I CT SCANNER SYSTEM
K991716 · JAK
Ge Medical Systems, Inc.
Radiology · 29d
Cleared Jun 18, 1999
STATUS CUP ACCUSIGN CUP
K991751 · DKE
Princeton BioMeditech Corp.
Toxicology · 25d
Cleared Jun 17, 1999
DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS
K983922 · JWY
Dade Microscan, Inc.
Microbiology · 225d
Cleared Jun 17, 1999
MALE NATURAL RUBBER LATEX CONDOM (WITH LUBRICATION)
K990925 · HIS
Hardcover Products, Inc.
Obstetrics & Gynecology · 90d
Cleared Jun 17, 1999
3D ANATOMICAL MESH
K990930 · FTL
Santerra Medical Technology, Inc.
General & Plastic Surgery · 90d
Cleared Jun 17, 1999
ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM
K991179 · DDC
Zeus Scientific, Inc.
Immunology · 71d
Cleared Jun 17, 1999
ISOSTAR I-125 INTERSTITIAL SEED, MODEL IS-12501
K991526 · KXK
Imagyn Medical Technologies, Inc.
Radiology · 45d
Cleared Jun 17, 1999
QUANTA LITE ANA ELISA
K991657 · LLL
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Jun 17, 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
K991876 · JPK
R&D Systems, Inc.
Hematology · 15d
Cleared Jun 16, 1999
REMOVABLE CUFF ABUTMENT
K984536 · DZE
Sulzer Calcitek, Inc.
Dental · 177d
Cleared Jun 16, 1999
OSTEOMED INTRAORAL DISTRACTION SYSTEM
K990944 · MQN
Osteomed Corp.
Dental · 86d
Cleared Jun 16, 1999
TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER
K991406 · FOZ
Terumo Medical Corp.
General Hospital · 55d
Cleared Jun 16, 1999
ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGAL
K991498 · JIA
Neometrics, Inc.
Chemistry · 48d
Cleared Jun 16, 1999
SSA-390A/POWER VISION 8000
K991858 · IYN
Toshiba America Medical Systems, In.C
Radiology · 15d
Cleared Jun 16, 1999
LYNX ULTRASOUND SYSTEM
K991872 · IYN
Ecton, Inc.
Radiology · 15d
Cleared Jun 16, 1999
ULTRA-SELECT GUIDEWIRE, HYTEK GUIDEWIRE
K991898 · DQX
Microvena Corp.
Cardiovascular · 12d