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
135817–135840 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 13, 1988
PRISMA DISPOSABLE ADAPTER FOR IRRIGATORS
K874989 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SILICONE BULB
K874990 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING IRIS HOOK
K874991 · HNQ
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE IRRIGATING LENS DIALER
K874992 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE SHARP IRRIGATING CYSTOTOME
K874993 · HNY
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ANGLED I/A CANNULA
K874994 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOS. CURVED LACHRYMAL CANNULA
K874995 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE KUGLEN IRRIGATING LENS MANIPULA.
K874996 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE STRAIGHT IRRIGATING CYSTOTOME
K874997 · HNY
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE U-SHAPED CANNULA
K874998 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ATKINSON RETROBULBAR NEEDLE
K874999 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 133d
Cleared Apr 13, 1988
PRISMA DISPOSABLE ENDO-OCULAR PROBE
K875000 · HQF
Advanced Surgical Products, Inc.
Ophthalmic · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE BLUNT IRRIGATING CYSTOTOME
K875001 · HNY
Advanced Surgical Products, Inc.
Ophthalmic · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE VISCOELASTIC I/A CANNULA
K875002 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 131d
Cleared Apr 13, 1988
PRISMA DISPOSABLE PUPIL CENTERING CANNULA
K875003 · HMX
Advanced Surgical Products, Inc.
Ophthalmic · 131d
Cleared Apr 13, 1988
ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
K875039 · LNK
Surgilase, Inc.
Gastroenterology & Urology · 128d
Cleared Apr 13, 1988
BFGOODRICH BIOTHANE NON-ADHERENT DRESSING
K875253 · NAD
The Bfgoodrich Co.
General & Plastic Surgery · 113d
Cleared Apr 13, 1988
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · LJT
Pharmacia Deltec, Inc.
General Hospital · 111d
Cleared Apr 13, 1988
SURGITEK NPT MONITOR
K875333 · LIL
Surgitek
Gastroenterology & Urology · 105d
Cleared Apr 13, 1988
CHRYS(TM) MODEL MED-MAX
K875338 · GEX
California Laboratories, Inc.
General & Plastic Surgery · 105d
Cleared Apr 13, 1988
MODIFIED PCA INFUSER
K875364 · FRN
Bd Becton Dickinson Vacutainer...
General Hospital · 105d
Cleared Apr 13, 1988
CHURCHILL 1.2 MICRON LIQUID FILTER SET
K880027 · FPB
Churchill Corp.
General Hospital · 99d
Cleared Apr 13, 1988
POLYDERM A+B(TM)
K880153 · NAD
Laivan Corp.
General & Plastic Surgery · 91d
Cleared Apr 13, 1988
480 HIGH-FLOW ULTRAFILTRATION CONTROL DIALYSATE
K880459 · FKP
Cd Medical, Inc.
Gastroenterology & Urology · 70d