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
113977–114000 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 29, 1993
SAS(TM) MONOCLONAL HCG-SLIDE
K930609 · JHJ
Sa Scientific, Inc.
Chemistry · 52d
Cleared Mar 29, 1993
CREATINE KINASE (CK) REAGENT SET
K930660 · CGS
Pointe Scientific, Inc.,
Chemistry · 48d
Cleared Mar 26, 1993
BIO-MATE PIC CATHETER
K920638 · FOZ
Medevice, Inc.
General Hospital · 408d
Cleared Mar 26, 1993
ACUSON V714 TRANSDUCER
K920882 · ITX
Acuson Corp.
Radiology · 394d
Cleared Mar 26, 1993
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · KPE
Baxter Healthcare Corp
General Hospital · 318d
Cleared Mar 26, 1993
SV 100200 - SINGLE USE ONLY - STERILE HOSPITAL KIT
K923281 · MDM
Savoy Medical Supply Co., Inc.
General & Plastic Surgery · 263d
Cleared Mar 26, 1993
REDUCED SHEAR OWR RECLINE SYSTEM
K923362 · ITI
Labac Systems, Inc.
Physical Medicine · 261d
Cleared Mar 26, 1993
TOPOGRAPHIC SCANNING SYSTEM TOPSS
K923742 · HLI
Carl Zeiss Meditec, Inc.
Ophthalmic · 242d
Cleared Mar 26, 1993
NIDEK CV-12000
K924260 · HQC
Nidek, Inc.
Ophthalmic · 214d
Cleared Mar 26, 1993
MEDTRONIC BIO-MEDICUS FEMORAL CANNULA/INTRODUCER
K924642 · DWF
Medtronic Bio-Medicus, Inc.
Cardiovascular · 193d
Cleared Mar 26, 1993
ELECTROPHORESIS CONTROL LEVEL 1
K925326 · JJY
Seradyn, Inc.
Chemistry · 156d
Cleared Mar 26, 1993
BCD ADVANCED BLOOD CARIOPLEGIA SYSTEMS
K925369 · DTR
Sorin Biomedica, Fiat, USA, Inc.
Cardiovascular · 154d
Cleared Mar 26, 1993
SHILEY SPECIALIZED,PEDIATRIC & NEONATAL TRACH.TUBE
K925615 · CBI
Sorin Biomedica, Fiat, USA, Inc.
Anesthesiology · 140d
Cleared Mar 26, 1993
INFRA-LINK
K926029 · IQA
Zygo Industries, Inc.
Physical Medicine · 115d
Cleared Mar 26, 1993
MAGMA XHF-30, XHF-40, XHF-50
K926365 · IZO
Imaging and X-Ray Intl., Inc.
Radiology · 94d
Cleared Mar 26, 1993
CANNULATED BIOPSY FORCEPS
K926430 · EOQ
Thomasville Medical Assoc.
Ear, Nose, Throat · 93d
Cleared Mar 26, 1993
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K926545 · JWY
Baxter Diagnostics, Inc.
Microbiology · 85d
Cleared Mar 26, 1993
STETSKINS
K930118 · BZS
Nova Diversified Concepts
Anesthesiology · 74d
Cleared Mar 26, 1993
RHEUMELISA II JO-1 ANTIBODY TEST KIT
K930757 · LLL
Biowhittaker Molecular Applications,...
Immunology · 42d
Cleared Mar 25, 1993
BARD LATEX URINARY CATHETERS
K922431 · KOD
C.R. Bard, Inc.
Gastroenterology & Urology · 307d
Cleared Mar 25, 1993
PROCLINIC ONE-STEP DIPSTICK PREGNANCY TEST
K930014 · JHI
Vanguard Biomedical Corp.
Chemistry · 80d
Cleared Mar 24, 1993
QUINEVAC II
K920629 · FYD
Recto Molded Products, Inc.
General Hospital · 406d
Cleared Mar 24, 1993
ABDOVAC (TM), BELLOVAC (TM) AND EXUDRAIN
K920819 · GCY
Astra Meditec AB
General & Plastic Surgery · 394d
Cleared Mar 24, 1993
MANUAL RECLINING CHAIR
K921028 · IOR
Labac Systems, Inc.
Physical Medicine · 386d