FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

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175,820 results
129913–129936 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 05, 1989
STEALTH DILATION CATHETER SYSTEM
K893411 · LIT
Target Therapeutics
Cardiovascular · 126d
Cleared Sep 05, 1989
MYOCARDIAL PROBE THERMOMETER CODE 64000
K893418 · FLL
Dlp, Inc.
General Hospital · 126d
Cleared Sep 05, 1989
BARD CATH LAB THERMODILUTION CATHETER
K893474 · DYG
C.R. Bard, Inc.
Cardiovascular · 124d
Cleared Sep 05, 1989
OXIMETER
K893587 · DQA
Radiometer America, Inc.
Anesthesiology · 119d
Cleared Sep 05, 1989
CALCIUM TEST ITEM NUMBER: 65409
K893778 · CIC
Em Diagnostic Systems, Inc.
Chemistry · 106d
Cleared Sep 05, 1989
VERIPOID 50 BIO-ELECTRICAL IMPEDANCE METER
K893963 · DSB
V.S.B.B. Technologies, Inc.
Cardiovascular · 95d
Cleared Sep 05, 1989
PATIENT EXAMINATION GLOVES
K894003 · LYY
Beekay Hygiene Products
General Hospital · 92d
Cleared Sep 05, 1989
ROCHE REAGENT FOR URIC ACID
K894101 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 88d
Cleared Sep 05, 1989
EMIT T-UPTAKE ASSAY
K894145 · KHQ
Syva Co.
Chemistry · 83d
Cleared Sep 05, 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K894146 · JWY
Baxter Healthcare Corp
Microbiology · 83d
Cleared Sep 05, 1989
MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL
K894148 · JDI
Howmedica Corp.
Orthopedic · 83d
Cleared Sep 05, 1989
BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT
K894173 · CDQ
Catachem, Inc.
Chemistry · 82d
Cleared Sep 05, 1989
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
K894317 · JOX
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
K894329 · JJX
Amersham Corp.
Chemistry · 53d
Cleared Sep 05, 1989
CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS
K894359 · JPA
Hemotec, Inc.
Hematology · 53d
Cleared Sep 05, 1989
ABBOTT TESTPACK PLUS HCG URINE
K894408 · JHI
Abbott Laboratories
Chemistry · 50d
Cleared Sep 05, 1989
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
K894466 · JPA
Hemotec, Inc.
Hematology · 49d
Cleared Sep 05, 1989
THROMBIN TIME REAGENT
K894467 · GJA
Sigma Chemical Co.
Hematology · 49d
Cleared Sep 05, 1989
GEMTAB SYSTEM
K894503 · JJQ
Pharmacia Eni Diagnostics, Inc.
Chemistry · 48d
Cleared Sep 05, 1989
ARBO H79P DISPOSABLE MONITORING ELECTRODES
K894562 · DRX
Arbo Medical, Inc.
Cardiovascular · 46d
Cleared Sep 05, 1989
#556 DISPOSABLE UMBILICAL CORD CLAMP (2)
K894646 · HFW
Alpha Unlimited, Inc.
Obstetrics & Gynecology · 43d
Cleared Sep 05, 1989
ARBO TAB DISPOSABLE DIAGNOSTIC RESTING EKG ELECTRO
K894648 · DRX
Arbo Medical, Inc.
Cardiovascular · 43d
Cleared Sep 05, 1989
ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33
K894718 · DTD
Intermedics, Inc.
Cardiovascular · 42d
Cleared Sep 05, 1989
SENTRY LATEX EXAMINATION GLOVES
K894849 · LYY
Vijayshree Spinning Mills , Ltd.
General Hospital · 36d