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
134809–134832 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 24, 1988
OHMEDA 5250 RGM (RESPIRATORY GAS MONITOR)
K882743 · CCL
Ohmeda Medical
Anesthesiology · 54d
Cleared Aug 24, 1988
SUNGLASSES, NON-PRESCRIPTION
K882769 · HQY
Spotlight Industries, Inc.
Ophthalmic · 49d
Cleared Aug 24, 1988
SPETZLER MANKIND VENTRICULOSTOMY EXTERNAL 1114-1
K883114 · JXG
Pmt Corp.
Neurology · 30d
Cleared Aug 24, 1988
OPTICAL OR EYEGLASS FRAME
K883226 · HQZ
Unique Optic , Ltd.
Ophthalmic · 23d
Cleared Aug 24, 1988
GENESIS II TRANSCRANIAL PROBE
K883238 · IYO
Biosound, Inc.
Radiology · 23d
Cleared Aug 24, 1988
MODIFIED SITE FIBER OPTIC MODULE FOR OPHTHAL. USE
K883480 · FCT
Site Microsurgical Systems, Inc.
Ophthalmic · 8d
Cleared Aug 23, 1988
GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS)
K873121 · LMD
General Electric Co.
Radiology · 378d
Cleared Aug 23, 1988
MD STRIPS BG
K875049 · CGA
Amatech International, Inc.
Chemistry · 258d
Cleared Aug 23, 1988
BD MICROFINE IV PEN INJECTOR
K881775 · FMF
Bd Becton Dickinson Vacutainer...
General Hospital · 119d
Cleared Aug 23, 1988
ENDO-ICE
K881826 · EAT
The Hygenic Corp.
Dental · 116d
Cleared Aug 23, 1988
AMISCO U-100 INSULIN SYRINGE
K882114 · FMF
American Intl. Medical Supply Co.
General Hospital · 97d
Cleared Aug 23, 1988
EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95
K882766 · DLG
Em Diagnostic Systems, Inc.
Toxicology · 48d
Cleared Aug 23, 1988
LASER MIXTURE
K882942 · GEX
Swisco, Inc.
General & Plastic Surgery · 47d
Cleared Aug 23, 1988
MASSAGE MACHINE (CAT. EM-01 ULE 111756)
K883064 · ISA
Emrad, Ltd.
Physical Medicine · 34d
Cleared Aug 23, 1988
PRISTINE XTRA, SURGEON'S GLOVE
K883244 · KGO
Japan World Medical Supply
General Hospital · 21d
Cleared Aug 23, 1988
CHOP SPINE FRAME
K883295 · LWG
Avec Scientific Design Corp.
General & Plastic Surgery · 19d
Cleared Aug 23, 1988
SUTURE RETENTION DEVICE
K883299 · KGS
Edwards Orthopaedics Div., Baxter...
General & Plastic Surgery · 19d
Cleared Aug 23, 1988
GASTROSTOMY FEEDING TUBE
K883336 · KNT
Gastrotech, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 23, 1988
SURGICAL SEALANT APPLICATOR
K883338 · KYZ
Micromedics, Inc.
General Hospital · 14d
Cleared Aug 23, 1988
PERCUTANEOUS ENDOSCOPIC GASTROSTOMY FEEDING TUBE
K883351 · KNT
Gastrotech, Inc.
Gastroenterology & Urology · 14d
Cleared Aug 23, 1988
MODEL 1080 ROLLER MASSAGE TABLE
K883357 · JFB
Excel Medical Products, Inc.
Physical Medicine · 14d
Cleared Aug 22, 1988
MODEL 5050 SURGILASER FOR OB-GYN USE
K871875 · HHR
Lasermatic, Inc.
Obstetrics & Gynecology · 466d
Cleared Aug 22, 1988
SUNGLASSES
K872786 · HQY
Quality Sunglasses, Ltd.
Ophthalmic · 405d
Cleared Aug 22, 1988
B & B I/A HANDPIECE
K881517 · KYG
B&B Medical Assoc., Inc.
Ophthalmic · 133d