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
136441–136464 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
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
Cleared Apr 12, 1988
ACCUTEK PERIODONTAL PROBE
K880827 · EIX
Sweet Micro Systems, Inc.
Dental · 42d
Cleared Apr 12, 1988
FOLDING HOSPITAL COT NSN 6530-00-299-8517
K881043 · FNJ
Junkin Safety Appliance Co., Inc.
General Hospital · 32d
Cleared Apr 12, 1988
PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES
K881108 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES
K881110 · LJG
Sigma Diagnostics, Inc.
Microbiology · 28d
Cleared Apr 12, 1988
ASO SLIDE TEST
K881209 · GTQ
Ncs Diagnostics, Inc.
Microbiology · 22d
Cleared Apr 12, 1988
STRAIGHT LENGTH ARCH WIRES
K881233 · EJF
Flexmedics
Dental · 21d
Cleared Apr 12, 1988
KODAK AUTOMATIC FILM FEEDER, MODEL 11
K881248 · IXW
Eastman Kodak Company
Radiology · 20d
Cleared Apr 12, 1988
CENTER BEND ARCH WIRES
K881274 · EJF
Flexmedics
Dental · 18d
Cleared Apr 12, 1988
HEARING AID (ALL-IN-THE-EAR)
K881296 · ESD
Hearing Aid Co.
Ear, Nose, Throat · 15d
Cleared Apr 11, 1988
VENTI-SCAN II
K871868 · IYT
Atomic Products Corp.
Radiology · 334d