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
134137–134160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 29, 1988
INTERMEDICS SELECT SHOULDER ALL PLASTIC GLEN. COMP
K881836 · KWS
Intermedics Orthopedics
Orthopedic · 119d
Cleared Aug 29, 1988
TEKNAR PERCU-SCAN
K881850 · IYO
Teknar, Inc.
Radiology · 119d
Cleared Aug 29, 1988
LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARD
K881868 · DPM
Supelco, Inc.
Toxicology · 118d
Cleared Aug 29, 1988
BIOPRO PC FEMORAL HIP COMPONENT
K882146 · JDI
Biopro, Inc.
Orthopedic · 98d
Cleared Aug 29, 1988
SERIES I AND II IMPLANTS
K882226 · DZE
Saber Technology, Inc.
Dental · 95d
Cleared Aug 29, 1988
EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS
K882313 · LDJ
Syva Co.
Toxicology · 87d
Cleared Aug 29, 1988
ELIMINATOR AIR FILTER
K882468 · KDQ
Apex Medical, Inc.
General Hospital · 75d
Cleared Aug 29, 1988
MODIFIED CONTINUOUS CARDIAC OUTPUT MONITOR SYSTEM
K882593 · DPW
Cardio Metrics, Inc.
Cardiovascular · 66d
Cleared Aug 29, 1988
LAD MODEL 633 LUMINOMETER
K882608 · JJQ
Los Alamos Diagnostics
Chemistry · 66d
Cleared Aug 29, 1988
PHARMACIA CHLAMYDIA EIA
K882676 · LJC
Pharmacia, Inc.
Microbiology · 62d
Cleared Aug 29, 1988
RAICHEM(TM) BILIRUBIN STANDARD
K882726 · JIS
Reagents Applications, Inc.
Chemistry · 59d
Cleared Aug 29, 1988
DADE(R) CK-MB IMMUNOASSAY CONTROL
K882795 · JJT
Baxter Healthcare Corp
Chemistry · 54d
Cleared Aug 29, 1988
RINSE & REFERENCE SOLUTION/BUFFER/LOW & HIGH STAN.
K882801 · JGS
Hf Scientific, Inc.
Chemistry · 53d
Cleared Aug 29, 1988
MEDIPAC II EC (TM), MODEL 7900
K882820 · GZJ
Medical Devices, Inc.
Neurology · 52d
Cleared Aug 29, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN
K882909 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 48d
Cleared Aug 29, 1988
EMIT QST CARBAMAZEPINE ASSAY
K882961 · KLT
Syva Co.
Toxicology · 46d
Cleared Aug 29, 1988
PMT SUBARACHNOID SCREW, MODEL NO.1350-2
K883115 · GWM
Pmt Corp.
Neurology · 35d
Cleared Aug 29, 1988
L-15 MEDIUM, CATALOG NO. 200-2021
K883362 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105
K883363 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505
K883364 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
HORSE SERUM, ABATTOIR, NO. 110-1112
K883365 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
MEDIUM 199, CATALOG NO. 200-2031
K883366 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
CALF SERUM, CATALOG NO. 110-1125
K883367 · KIT
J R Scientific
Pathology · 20d
Cleared Aug 29, 1988
NEWBORN CALF SERUM, CATALOG NO. 110-1130
K883368 · KIT
J R Scientific
Pathology · 20d