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
135841–135864 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 1988
BLAUSIEGEL TRANSPARENT CONDOMS
K871267 · HIS
Ticosan, Inc.
Obstetrics & Gynecology · 378d
Cleared Apr 12, 1988
BIOTROL TOXO ELISA TEST M
K873293 · LGD
Biotrol, USA, Inc.
Microbiology · 239d
Cleared Apr 12, 1988
BIOTROL TOXO ELISA TEST G
K873294 · LGD
Biotrol, USA, Inc.
Microbiology · 239d
Cleared Apr 12, 1988
E.W.L. P-TENS/H-WAVE FOR GENERAL DENTISTRY
K873604 · LWM
Electronic Waveform Laboratory, Inc.
Dental · 221d
Cleared Apr 12, 1988
KETAC-BOND APLICAP
K874788 · EMA
Espe GmbH (Us)
Dental · 141d
Cleared Apr 12, 1988
CONDOMS (RAMSES EXTRA, SHEIK ELITE AND KOROMEX)
K874791 · HIS
Schmid Laboratories, Inc.
Obstetrics & Gynecology · 141d
Cleared Apr 12, 1988
TOXOSTAT M TEST KIT
K875113 · LGD
Whittaker Bioproducts, Inc.
Microbiology · 119d
Cleared Apr 12, 1988
INVESTIGATION KIT, SEXUAL ASSAULT DETERMINATION
K880208 · EFQ
Dresser Argus, Inc.
General & Plastic Surgery · 88d
Cleared Apr 12, 1988
MERITEC(TM)-CAMPY (JCL)
K880389 · LQP
Meridian Diagnostics, Inc.
Microbiology · 75d
Cleared Apr 12, 1988
LEPTOSPIROSIS IHA
K880417 · GRY
Hillcrest Biologicals
Microbiology · 71d
Cleared Apr 12, 1988
GRAM NEGATIVE MIC/COMBO PANELS
K880430 · JWY
Baxter Healthcare Corp
Microbiology · 71d
Cleared Apr 12, 1988
V-TREND STREP A TEST
K880483 · GTZ
Texas Immunology, Inc.
Microbiology · 67d
Cleared Apr 12, 1988
G-CERA PORCELAIN & G-CERA PORCELAIN MODIFIER
K880764 · ELL
G-C Intl. Corp.
Dental · 46d
Cleared Apr 12, 1988
PATHFINDER(TM) CHLAMYDIA EIA DETECTION KIT
K880824 · LJC
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 42d