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
125353–125376 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 06, 1990
LUER LOCK TRANSFER PIN
K901063 · LHI
Acacia, Inc.
General Hospital · 121d
Cleared Jul 06, 1990
CODE #94315 RETROGRADE CORONARY SINUS PERF CANNULA
K901074 · DWF
Dlp, Inc.
Cardiovascular · 120d
Cleared Jul 06, 1990
HOLLOW MOTOR DRIVE UNIT
K901601 · LIT
Devices For Vascular Intervention, Inc.
Cardiovascular · 91d
Cleared Jul 06, 1990
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · DXE
Baxter Healthcare Corp
Cardiovascular · 88d
Cleared Jul 06, 1990
APPLIED VASCULAR DEVICES 6MM TRACTION CLIP
K901628 · DXC
Applied Vascular Devices, Inc.
Cardiovascular · 88d
Cleared Jul 06, 1990
RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT
K901672 · EIA
Pelton & Crane Co.
Dental · 87d
Cleared Jul 06, 1990
CVIS INSIGHT 15MHZ CATHETERS FOR PERIPHERAL USE
K901691 · DQO
Cardiovascular Imaging Systems, Inc.
Cardiovascular · 87d
Cleared Jul 06, 1990
GE SIGNA ADVANTAGE
K901730 · LNH
GE Medical Systems
Radiology · 81d
Cleared Jul 06, 1990
EQUI-GUARD (ASPIRATOR FILTER)
K902089 · GCX
Equi-Tron Mfg., Inc.
General Hospital · 58d
Cleared Jul 06, 1990
MODIFIED EPICARDIAL ARRAY
K902228 · DRF
C.R. Bard, Inc.
Cardiovascular · 50d
Cleared Jul 06, 1990
CARDIOCAP II MONITORS: CH, CH-2, CH-S, CH-2S
K902492 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
CARDIOCAP II CG-2GS, 2G, 1GS, 1G, 2CG, CS MONITOR
K902493 · DRI
Datex Division Instrumentarium Corp.
Cardiovascular · 31d
Cleared Jul 06, 1990
WHITESIDE ORTHOLOC MODULAR TIBIAL AUGMENTATION
K902538 · HRY
Dow Corning Wright
Orthopedic · 30d
Cleared Jul 05, 1990
POLYSORB SYNTHETIC ABSORBABLE SUTURE
K895579 · GAN
United States Surgical, A Division of...
General & Plastic Surgery · 293d
Cleared Jul 05, 1990
DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P.
K900198 · GAN
American Cyanamid Co.
General & Plastic Surgery · 170d
Cleared Jul 05, 1990
NONABSORBABLE NYLON SURGICAL SUTURE*
K900531 · GAR
United States Surgical, A Division of...
General & Plastic Surgery · 150d
Cleared Jul 05, 1990
MODIFIED APSARA CLINICAL DIAGNOSTIC ANALYZER
K900788 · CEM
Datachem, Inc.
Chemistry · 135d
Cleared Jul 05, 1990
SUNGLASSES
K900944 · HQY
K Mart Apparel Corp.
Ophthalmic · 127d
Cleared Jul 05, 1990
60 FUNDUS CAMERA CF-60UV
K901839 · HJI
Canon USA, Inc.
Ophthalmic · 72d
Cleared Jul 05, 1990
SUNGLASSES - IMPACT RESISTANT LENSES (ACRYLIC)
K901945 · HQY
Zebco Corp.
Ophthalmic · 66d
Cleared Jul 05, 1990
STRIPE PROJECTOR
K902138 · HJI
Academic Catalyst Corp.
Ophthalmic · 56d
Cleared Jul 05, 1990
PIEZO HANDPIECE
K902150 · HQC
United Surgical Corp.
Ophthalmic · 51d
Cleared Jul 05, 1990
TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES
K902243 · KLS
Technicon Instruments Corp.
Chemistry · 48d
Cleared Jul 05, 1990
SOLAR-MATES SUNGLASSES, BONJOUR EYEWEAR
K902322 · HQY
Nevitt Sales Corp.
Ophthalmic · 42d