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
85465–85488 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Jun 15, 1999
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD...
K990949 · CAH
Intersurgical, Inc.
General Hospital · 85d
Cleared Jun 15, 1999
CLIMAX
K991049 · HIS
Medilatex Sdn. Bhd.
Obstetrics & Gynecology · 77d
Cleared Jun 15, 1999
INVIGRA
K991374 · HIS
Indus Medicare , Ltd.
Obstetrics & Gynecology · 55d
Cleared Jun 15, 1999
DAHEDI INSULIN INFUSION PUMP
K991376 · LZG
Disetronic Medical Systems
General Hospital · 55d
Cleared Jun 15, 1999
XANTOPREN COMFORT
K991425 · ELW
Heraeus Kulzer, Inc.
Dental · 53d
Cleared Jun 15, 1999
CADD ADMINISTRATION SET
K991599 · FPA
Sims Deltec, Inc.
General Hospital · 36d
Cleared Jun 15, 1999
MODIFICATION OF: STERRAD BI TEST PACK
K991675 · FRC
Advanced Sterilization Products
General Hospital · 29d
Cleared Jun 15, 1999
CORDIS MAXI DS PTA BALLOON CATHETER
K991811 · LIT
Cordis Corp.
Cardiovascular · 19d
Cleared Jun 15, 1999
CONMED STEALTH NON-STICK ACCESSORY ELECTRODE, MODEL 138XXX
K991855 · GEI
Conmedcorp
General & Plastic Surgery · 14d