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
127729–127752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Feb 16, 1990
SHARPLAN ND:YAG LASER FOR ARTHROSCOPY/MENISCECTOMY
K896762 · GEX
Sharplan Lasers, Inc.
General & Plastic Surgery · 77d
Cleared Feb 16, 1990
DISPOSABLE URODYNAMIC CATHETER SET
K896784 · KOD
Life-Tech Intl., Inc.
Gastroenterology & Urology · 74d
Cleared Feb 16, 1990
SUCTION CATHETER KIT
K896797 · BSY
Westmark, Sterile Packing Systems,...
Anesthesiology · 77d
Cleared Feb 16, 1990
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
K896845 · CDL
Reagents Applications, Inc.
Chemistry · 72d
Cleared Feb 16, 1990
CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE
K896935 · FYA
Baxter Healthcare Corp
General Hospital · 65d
Cleared Feb 16, 1990
MOBILE X-RAY PERSONNEL PROTECTIVE SCREENS
K896949 · EAK
Innovative Products Mfg.
Radiology · 65d
Cleared Feb 16, 1990
PORT INFUSION SET (PIS) INFUSION SET (IS)
K897065 · FPA
Prn Services, Inc.
General Hospital · 58d
Cleared Feb 16, 1990
MODEL 2800 ND:YAG OPHTHALMIC LASER
K897099 · GEX
Alcon Surgical, Inc.
General & Plastic Surgery · 57d
Cleared Feb 16, 1990
MULTI-CHANNEL ISOLATION AMPLIFIER (MCIA)
K900063 · GWL
Bio-Feedback Systems, Inc.
Neurology · 44d
Cleared Feb 16, 1990
MODIFIED USES OF THE ARTHROSCOPIC SURGICAL SYSTEM
K900070 · HRX
Dyonics, Inc.
Orthopedic · 43d