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
134233–134256 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Aug 22, 1988
INFUSION HANDLE
K881518 · KYG
B&B Medical Assoc., Inc.
Ophthalmic · 133d
Cleared Aug 22, 1988
RETRACTIVE INCISION MICROMETER (RIM) GUAGE
K882402 · HNN
Optical Center
Ophthalmic · 73d
Cleared Aug 22, 1988
IOL IMPLANTATION FORCEPS
K883197 · HNR
D & D Surgical
Ophthalmic · 25d
Cleared Aug 22, 1988
EV MONOCANALICULAR STENT (TM)
K883233 · OKS
Eagle Vision, Inc.
Ophthalmic · 21d
Cleared Aug 19, 1988
3000 PHYSIOLOGICAL MONITOR
K880301 · DXG
Datascope Corp.
Cardiovascular · 207d
Cleared Aug 19, 1988
ADDITIONAL CLAIMS TO DENTAL RESTORATIVE COMP. KIT
K880562 · DYH
Macrochem Corp.
Dental · 190d
Cleared Aug 19, 1988
COATING FOR WIRE GUIDE
K880722 · DQX
Cook, Inc.
Cardiovascular · 178d
Cleared Aug 19, 1988
TAPER-22 STEERABLE GUIDEWIRE
K880761 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
TAPER FLEX-TIP STEERABLE GUIDEWIRE
K880762 · DQX
Target Therapeutics
Cardiovascular · 176d
Cleared Aug 19, 1988
ECG MONITOR AND RESPIRATION PACER
K881055 · DPS
D. E. Hokanson, Inc.
Cardiovascular · 164d
Cleared Aug 19, 1988
OXYGEN/TEMPERATURE ANALYZER MODEL 300 SERIES
K881663 · CCL
Salter Labs
Anesthesiology · 126d
Cleared Aug 19, 1988
RESPIRONIC'S INFANT SECUREEASY
K882079 · CBH
Respironics, Inc.
Anesthesiology · 94d
Cleared Aug 19, 1988
NIDEK US-3000
K882162 · IYO
Nidek, Inc.
Radiology · 88d
Cleared Aug 19, 1988
EXTERNAL PACEMAKER 2000 (EP2000)
K882168 · DRO
Unomed, Inc.
Cardiovascular · 87d