Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
82129–82152 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 06, 2000
BREEZE SLEEPGEAR WITH DREAMSEAL
K002001 · BZD
Puritan Bennett Corp.
Anesthesiology · 68d
Cleared Sep 06, 2000
PHILIPS INTEGRIS ALLURA
K002016 · OWB
Philips Medical Systems North...
Radiology · 65d
Cleared Sep 06, 2000
CAPIOX ARTERIAL FILTER
K002026 · DTM
Terumo Medical Corp.
Cardiovascular · 65d
Cleared Sep 06, 2000
S/5 COMPACT CRITICAL CARE MONITOR WITH S-00C03 OR S-00C04 SOFTWARE
K002158 · MHX
Datex-Ohmeda, Inc.
Cardiovascular · 51d
Cleared Sep 06, 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS...
K002574 · DQA
Masimo Corp.
Anesthesiology · 19d
Cleared Sep 06, 2000
DIGITAL BLOOD PRESSURE MONITOR, MODEL MD-550
K002655 · DXN
Meditec Co., Ltd.
Cardiovascular · 12d
Cleared Sep 06, 2000
COAGUCHEK S SYSTEM, MODEL 2138280
K994349 · JPA
Roche Diagnostics Corp.
Hematology · 258d
Cleared Sep 05, 2000
CAMIT DIABETES MANAGEMENT SOFTWARE
K001907 · CGA
Roche Diagnostics Corp.
Chemistry · 75d
Cleared Sep 05, 2000
INVIDOS
K002051 · IYE
Scanditronix Medical AB
Radiology · 61d
Cleared Sep 05, 2000
LINEZOLID, 30UG, BBL SENSI-DISC
K002165 · JTN
Dickinson, and Co.
Microbiology · 49d
Cleared Sep 05, 2000
INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
K002380 · FRN
Baxter Healthcare Corp
General Hospital · 32d
Cleared Sep 05, 2000
OBC-63 MEBREAST ARRAY COIL
K002602 · MOS
Mri Devices Corp.
Radiology · 15d
Cleared Sep 05, 2000
TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM
K002609 · DHR
Roche Diagnostics Corp.
Immunology · 14d
Cleared Sep 05, 2000
PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM
K993675 · MUJ
Nomos Corp.
Radiology · 309d
Cleared Sep 05, 2000
OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR...
K994103 · ITX
Olympus America, Inc.
Radiology · 274d
Cleared Sep 01, 2000
STRATO X
K002432 · EHD
Villa Sistemi Medicali S.P.A.
Radiology · 24d
Cleared Sep 01, 2000
FENNING HIP STEM
K002441 · LZO
DePuy Orthopaedics, Inc.
Orthopedic · 23d
Cleared Sep 01, 2000
EQUIPMENT DRAPES
K002508 · KKX
Allegiance Healthcare Corp.
General Hospital · 17d
Cleared Aug 31, 2000
LIFE SCOPE EC, MODEL BSM-1102
K000517 · MHX
Nihon Kohden America, Inc.
Cardiovascular · 197d
Cleared Aug 31, 2000
SENSIDYNE OXYGEN ANALYZER & SENSIDYNE OXYGEN MONITOR
K000700 · CCL
Sensidyne, Inc.
Anesthesiology · 183d
Cleared Aug 31, 2000
128 CHANNEL EEG HEADBOX, MODEL EX-NW-128
K000919 · GWQ
Excel Tech. , Ltd.
Neurology · 162d
Cleared Aug 31, 2000
GAZELLE BALLOON DILATATION CATHETER
K001134 · LIT
Boston Scientific Corp
Cardiovascular · 143d
Cleared Aug 31, 2000
IMPULSE SELECT
K001579 · NFB
Airsep Corp.
Anesthesiology · 101d
Cleared Aug 31, 2000
ATHOS
K001704 · GEX
Cosmos Medical Technology
General & Plastic Surgery · 87d