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
115057–115080 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 15, 1992
COX DISPOSABLE ENDOSCOPE CLEANING BRUSH(CB-X2)
K924655 · FEB
Cox Medical Ent., Inc.
General Hospital · 91d
Cleared Dec 15, 1992
ZYMED TELEMETRY MONITOR MODEL T8010 (PRELIMINARY)
K924672 · DSI
Agilent Technologies
Cardiovascular · 90d
Cleared Dec 15, 1992
MICROFLOW
K924684 · CAF
Mountain Medical Equipment, Inc.
Anesthesiology · 90d
Cleared Dec 15, 1992
BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE
K924753 · HMJ
Bioenterics Corp.
Ophthalmic · 84d
Cleared Dec 15, 1992
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K924858 · DBF
Tosoh Medics, Inc.
Immunology · 78d
Cleared Dec 15, 1992
QUANTA LITE(TM) SCL-70 ELISA
K924898 · LLL
Inova Diagnostics, Inc.
Immunology · 78d
Cleared Dec 11, 1992
SAM ST
K913097 · BTI
Ferguson Medical
Anesthesiology · 518d
Cleared Dec 11, 1992
ADVANCE STOPCOCK/HIGH PRESSURE STOPCOCK
K915301 · DTL
Advance Medical Designs, Inc.
Cardiovascular · 386d
Cleared Dec 11, 1992
POCKET SIZE FETAL HEART DETECTOR
K920056 · KNG
Medical Accessories, Inc.
Radiology · 340d
Cleared Dec 11, 1992
CUT RESISTANT GLOVES OR SURGICAL GLOVE LINER
K920876 · KGO
Medtech Intl., Inc.
General Hospital · 289d
Cleared Dec 11, 1992
MERITRANS(TM) DISPOSABLE TRANSDUCER
K920977 · DRS
Merit Medical Systems, Inc.
Cardiovascular · 284d
Cleared Dec 11, 1992
SOFT-TEMP
K921920 · DWJ
Adroit Medical Systems, Inc.
Cardiovascular · 232d
Cleared Dec 11, 1992
2ND SKIN STERILE ADHESIVE STRIP
K922228 · KGX
Spenco Medical Corp.
General & Plastic Surgery · 213d
Cleared Dec 11, 1992
M-LINK
K922303 · KPS
Medimage, Inc.
Radiology · 210d
Cleared Dec 11, 1992
SUTURE REMOVAL KIT
K922339 · MCZ
Transidyne General Corp.
General & Plastic Surgery · 206d
Cleared Dec 11, 1992
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · JWY
Baxter Healthcare Corp
Microbiology · 199d
Cleared Dec 11, 1992
LYRIS 100/120 LABORATORY INFORMATION SYSTEM
K923844 · JJQ
Biovation, Inc.
Chemistry · 133d
Cleared Dec 11, 1992
WATERS(TM) 996 PDA
K924347 · KIE
Millipore Corp.
Toxicology · 106d
Cleared Dec 11, 1992
TRACHEOSTOMY TUBE AND TUBE CUFF
K924660 · JOH
Applied Medical Resources
Anesthesiology · 87d
Cleared Dec 11, 1992
SOLARCARE TECHNOLOGIES CORP. MICRO-PLATE PCP ASSAY
K924751 · LCM
Solarcare Technologies Corp,Inc.
Toxicology · 79d
Cleared Dec 11, 1992
OPUS(R) VANCOMYCIN
K924957 · LEH
Pb Diagnostic Systems, Inc.
Toxicology · 72d
Cleared Dec 11, 1992
OLYMPUS CHLORIDE REAGENT
K925338 · CHJ
Olympus Corp.
Chemistry · 52d
Cleared Dec 10, 1992
MINI DOPPLER II ULTRASOUND BLOOD FLOW DETECTOR
K915550 · DPW
Koven and Assoc., Inc.
Radiology · 365d
Cleared Dec 10, 1992
OPHTHALMIC KNIFE
K922378 · HNN
Microptics Development Laboratory
Ophthalmic · 204d