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
122305–122328 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 26, 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · DSI
Hewlett-Packard Co.
Cardiovascular · 80d
Cleared Apr 26, 1991
SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2
K910597 · HQY
Radix Group Intl.
Ophthalmic · 73d
Cleared Apr 26, 1991
DISPOSABLE IRRIGATING/ASPIRATING HANDPIECE
K910973 · HQE
Surgical Technologies, Inc.
Ophthalmic · 50d
Cleared Apr 25, 1991
COMPAC(TM) DIODE LASERS
K904699 · HQF
Hgm Medical Laser Systems, Inc.
Ophthalmic · 191d
Cleared Apr 25, 1991
CONSUMER SENSORY PRODUCTS BIO-LOG 8000
K904955 · FLL
Consumer Sensory Products, Inc.
General Hospital · 171d
Cleared Apr 25, 1991
PHARM-ASSIST
K905116 · LHI
Excel Medical, Inc.
General Hospital · 163d
Cleared Apr 25, 1991
ENDOSCOPE AND ACCESSORIES
K905117 · GCI
Northgate Technologies, Inc.
General & Plastic Surgery · 163d
Cleared Apr 25, 1991
SPLASH GUARD
K905173 · KYZ
E.M. Adams
General Hospital · 160d
Cleared Apr 25, 1991
STANDARD RUBBER DAM WITH OR WITHOUT FRAMES
K905470 · EIE
Elastomade Accessories Sdn Bhd
Dental · 140d
Cleared Apr 25, 1991
AMS 700 ULTREX(TM) PRECONNECTED PENILE PROSTHESIS
K910214 · FAE
American Medical Corp.
Gastroenterology & Urology · 98d
Cleared Apr 25, 1991
SURGICAL GOWNS, EXTRA-LARGE SIZE
K910410 · FYC
Dawn of Hope Development Center
General Hospital · 86d
Cleared Apr 25, 1991
WILSON-COOK DISPOSABLE BIOPSY FORCEPS
K910656 · FLC
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 70d
Cleared Apr 25, 1991
DISPOSABLE ELECTROSURGICAL BLADE
K910779 · GEI
Conmedcorp
General & Plastic Surgery · 59d
Cleared Apr 25, 1991
PLASTIC (VINYL) EXAMINATION GLOVES
K910879 · LYZ
Siamount Plastic Corporation , Ltd.
General Hospital · 55d
Cleared Apr 25, 1991
TONGUETOUCH KEYPAD AND ZOFCOM CONTROL SYSTEM
K911101 · IQA
Zofcom, Inc.
Physical Medicine · 43d
Cleared Apr 25, 1991
APPLICATOR LOOP SUTURES
K911157 · GCJ
Northgate Technologies, Inc.
General & Plastic Surgery · 41d
Cleared Apr 25, 1991
STERILE POLYPROPYLENE MONFIL NONABSORB SURG SUTURE
K911189 · GAW
Internacional Farmaceutica, S.A. DE C.V.
General & Plastic Surgery · 38d
Cleared Apr 25, 1991
KENDALL PEDIATRIC ULTRAMER POLYURETHANE CATHETER
K911242 · KOD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 35d
Cleared Apr 25, 1991
EUDERMIC SURGICAL GLOVES
K911245 · KGO
Bd Becton Dickinson Vacutainer...
General Hospital · 35d
Cleared Apr 25, 1991
KENDALL PEDIATRIC URINE METER
K911258 · EXR
Kendall Healthcare Products Co....
Gastroenterology & Urology · 34d
Cleared Apr 25, 1991
BARD 3000 PLUS URETEROSCOPY SYSTEM
K911411 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 24d
Cleared Apr 25, 1991
SURGITRON
K911461 · GCI
Ellman Intl. Mfg., Inc.
General & Plastic Surgery · 22d
Cleared Apr 25, 1991
LAPAROSCOPIC SUCTION/IRRIGATION CANNULA
K911486 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 21d
Cleared Apr 25, 1991
LAPAROSCOPIC IRRIGATION PUMP
K911493 · GCJ
United States Endoscopy Group, Inc.
General & Plastic Surgery · 21d