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
136417–136440 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 13, 1988
DX101 ULTRASONIC SURGICAL SYSTEM
K880814 · LFL
Niic U.S.A., Inc.
General & Plastic Surgery · 56d
Cleared Apr 13, 1988
DX101-T ULTRASONIC SURGICAL SYSTEM
K880815 · LFL
Niic U.S.A., Inc.
General & Plastic Surgery · 56d
Cleared Apr 13, 1988
DISPOSABLE WET FIELD ERASER
K880925 · GXI
Advanced Surgical Products, Inc.
Neurology · 40d
Cleared Apr 13, 1988
DISPOSABLE COAXIAL BIPOLAR PEN P/N 00150
K880951 · GXI
Advanced Surgical Products, Inc.
Neurology · 37d
Cleared Apr 13, 1988
AL-200B MUSCLE ACTIVITY INTEGRATOR
K880976 · IKN
Aaron Laboratories, Inc.
Neurology · 36d
Cleared Apr 13, 1988
ADR-2000 AMBULATORY DATA RECORDING SYSTEM
K880977 · IKN
Aaron Laboratories, Inc.
Neurology · 36d
Cleared Apr 13, 1988
SURGIN EYE SHIELD
K881232 · HOY
Surgeon Surgical Instrumentation, Inc.
Ophthalmic · 22d
Cleared Apr 13, 1988
COX RAPID HEAT TRANSFER STERILIZER W/12 MIN. CYCLE
K881371 · KMH
Cox Sterile Products, Inc.
General Hospital · 12d
Cleared Apr 13, 1988
PSORALITE PHOTOTHERAPY TREATMENT BOOTH/PANEL
K881385 · FTC
Psoralite Corp.
General & Plastic Surgery · 9d
Cleared Apr 13, 1988
NANOLAS ND:YAG OPHTHALMIC LASER
K881459 · LOI
Biophysic Medical, Inc.
Ophthalmic · 7d