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
127129–127152 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 16, 1990
IMAGES-ON-CALL TELERADIOLOGY SYSTEM
K896095 · LMD
Devices & Services Co.
Radiology · 119d
Cleared Feb 16, 1990
WILLIAMS PENILE ANESTHETIC RETAINER
K896160 · FHA
Cook Urological, Inc.
Gastroenterology & Urology · 115d
Cleared Feb 16, 1990
REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083
K896170 · JHT
Helena Laboratories
Chemistry · 114d
Cleared Feb 16, 1990
COBAS READY URIC ACID REAGENT
K896227 · KNK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CARDIO PROFILE REAGENT STRIP
K896228 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY PROFILE 1 REAGENT STRIP
K896229 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TOTAL PROTEIN REAGENT
K896230 · CEK
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY TRIGLYCERIDE REAGENT
K896231 · CDT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY LIVER PROFILE REAGENT STRIP
K896233 · CIT
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY STAT PROFILE REAGENT STRIP
K896234 · CKA
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY ALT REAGENT
K896237 · CKD
Roche Diagnostic Systems, Inc.
Chemistry · 108d
Cleared Feb 16, 1990
COBAS READY AST REAGENT
K896238 · CIS
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CHOLESTEROL REAGENT
K896239 · CHH
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY CK REAGENT
K896240 · JHY
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
COBAS READY LDH REAGENT
K896241 · CFJ
Roche Diagnostic Systems, Inc.
Chemistry · 109d
Cleared Feb 16, 1990
QUIDEL GROUP B STREP TEST
K896265 · GTZ
Quidel Corp.
Microbiology · 108d
Cleared Feb 16, 1990
KENLOR PYROGALLOL RED MICROPROTEIN ASSAY KIT
K896440 · JIR
Kenlor Industries, Inc.
Chemistry · 99d
Cleared Feb 16, 1990
MODIFIED PARAMAX URIC ACID REAGENT
K896521 · KNK
Baxter Healthcare Corp
Chemistry · 93d
Cleared Feb 16, 1990
CANTATA EMG/EVOKED RESPONSE SYSTEM
K896567 · GWF
Dantec Medical, Inc.
Neurology · 88d
Cleared Feb 16, 1990
MODIFIED HCG ENZYME IMMUNOASSAY TEST KIT
K896587 · JHI
Medix Biotech, Inc.
Chemistry · 87d
Cleared Feb 16, 1990
FLAT VASCULAR PROBE
K896613 · DPW
Imex Medical Systems, Inc.
Cardiovascular · 87d
Cleared Feb 16, 1990
SAFECON CONDOMS - PINK COLOR
K896623 · HIS
Quality Synthetics Intl, Inc.
Obstetrics & Gynecology · 87d
Cleared Feb 16, 1990
P460, DG32 ELECTROENCEPHALOGRAPH
K896666 · GWQ
Teca, Inc.
Neurology · 81d
Cleared Feb 16, 1990
4 SURE UROLOGICAL CATHETER
K896725 · KOD
The Boston & Pacific Co., Inc.
Gastroenterology & Urology · 79d