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
147361–147384 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 29, 1985
BLOOD TUBING SET
K852605 · FJK
Medflex International, Inc.
Gastroenterology & Urology · 40d
Cleared Jul 29, 1985
CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353
K852678 · KDJ
Travenol Laboratories, S.A.
Gastroenterology & Urology · 34d
Cleared Jul 29, 1985
FIBERLASE 100 MEDICAL LASER SYSTEM
K852798 · LNK
Laser Media
Gastroenterology & Urology · 28d
Cleared Jul 29, 1985
STERILE DISPOSABLE SYRINGES(2 PIECES)
K852818 · FMF
Fabersanitas, S.A.
General Hospital · 28d
Cleared Jul 29, 1985
DISPOSABLE VVC(VOLUME VENTILATOR CIRCUIT)
K852821 · BZD
Puritan Bennett Corp.
Anesthesiology · 27d
Cleared Jul 29, 1985
SLIM VENT UNIPO PACING LEAD USING POLYU 90A,30-281
K852915 · DTB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM VENT BIPO PACING LEAD USING A90 INSUL,#30-284
K852916 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART/J-SVC IND PACING LEAD USING POLY #30-283
K852917 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
SLIM ART J. BIP PACING LEAD USING POLY #030-2821
K852918 · DYB
Telectronics, Inc.
Cardiovascular · 35d
Cleared Jul 29, 1985
HUCK TOWEL
K852945 · KKX
South Mountain Medical
General Hospital · 18d
Cleared Jul 29, 1985
SAHARA SUNBED
K852957 · FTC
Sahara Sun Beds., Inc.
General & Plastic Surgery · 17d
Cleared Jul 29, 1985
P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION
K852964 · DXQ
Howmedica Corp.
Cardiovascular · 17d
Cleared Jul 29, 1985
REICHERT FLEXIBLE LARYNGOSCOPE, MODEL LS-11
K852994 · CAL
Reichert-Jung, Inc.
Anesthesiology · 14d
Cleared Jul 29, 1985
SELF-CENTERING BONE HOLDING FORCEPS, 10-1/4 SS420
K853015 · GEN
The Huxley Instrument Corp.
General & Plastic Surgery · 12d
Cleared Jul 26, 1985
STERILE CATHETERS-CATHETER PERITONEAL LONG-TERM IN
K850214 · FJS
Accurate Surgical Instruments Co.
Gastroenterology & Urology · 185d
Cleared Jul 26, 1985
COMPUTE RX-PLAN
K850977 · KPQ
Medicalibration
Radiology · 140d
Cleared Jul 26, 1985
HAEMODIALYSIS SETS & DIALIFLEX FISTULA NEEDLES
K851236 · FJK
Infarkem Corp.
Gastroenterology & Urology · 121d
Cleared Jul 26, 1985
VARICES INJECTOR
K851952 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 84d
Cleared Jul 26, 1985
DIASONICS, BERGER STEREOTACTIC NEOROBIOPSY
K851973 · HAW
Diasonics, Inc.
Neurology · 80d
Cleared Jul 26, 1985
ERIKA ART LI, 3-9621-8, 22-6, 23-4 & VEN 9714-1
K852309 · FJK
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 26, 1985
NATURALYTE BICARBONATE CONCENTRATE-DRY PACK
K852310 · FKQ
Erika, Inc.
Gastroenterology & Urology · 58d
Cleared Jul 26, 1985
TRICOT ADHESIVE BANDAGE
K852462 · KGX
American White Cross, Inc.
General & Plastic Surgery · 46d
Cleared Jul 26, 1985
TAYLOR PERCUSSION HAMMER SS 410 OR 420
K852716 · GWZ
The Huxley Instrument Corp.
Neurology · 30d
Cleared Jul 26, 1985
STERILE, DISPOSABLE NEEDLE
K852817 · GAA
Fabersanitas, S.A.
General & Plastic Surgery · 25d