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
136705–136728 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 24, 1988
LUMISCOPE TENS MODEL 2000T OR APCC 3001 OR PAIN RE
K880452 · GZJ
Lumiscope Co., Inc.
Neurology · 51d
Cleared Mar 24, 1988
STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR
K880467 · JIY
Stanbio Laboratory
Chemistry · 50d
Cleared Mar 24, 1988
WORD BARTHOLIN GLAND CATHETER CODE: 1005
K880497 · KNA
Hoosier Specialties, Inc.
Obstetrics & Gynecology · 48d
Cleared Mar 24, 1988
TOTAL IRON BINDING CAPACITY (TIBC)
K880546 · JMO
Boehringer Mannheim Corp.
Chemistry · 44d
Cleared Mar 24, 1988
UTILITY WAX STRIPS, CINNAMON
K880606 · EGD
Columbus Dental Mfg. Co.
Dental · 41d
Cleared Mar 24, 1988
UNIMETER CALIBRATION KIT
K880610 · JIW
Boehringer Mannheim Corp.
Chemistry · 41d
Cleared Mar 24, 1988
EMIT THYROXINE ASSAY
K880620 · KLI
Syva Co.
Chemistry · 37d
Cleared Mar 24, 1988
PARAMAX AMMONIA REAGENT
K880651 · JIF
Baxter Healthcare Corp
Chemistry · 36d
Cleared Mar 24, 1988
INORGANIC PHOSPHORUS REAGENT SET
K880676 · CEO
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
TOTAL PROTEIN REAGENT SET
K880677 · CEK
Tech-Neal Scientific, Inc.
Chemistry · 34d
Cleared Mar 24, 1988
CORTISOL ENHANCED LUMINESCENCE ASSAY KIT
K880687 · CGR
Amersham Corp.
Chemistry · 31d
Cleared Mar 24, 1988
QUANTIMETRIX SERUM ENZYME CONTROL
K880701 · JJT
Quantimetrix Corp.
Chemistry · 31d
Cleared Mar 24, 1988
PROTEIN BASE ISE CONTROL
K880710 · JJR
Bionostics, Inc.
Chemistry · 31d
Cleared Mar 24, 1988
WAKO AUTOKIT URIC ACID
K880731 · KNK
Wako Chemicals USA, Inc.
Chemistry · 29d
Cleared Mar 24, 1988
ATS 0.2% BOVINE ALBUMIN FRACTION V SOLUTION
K880990 · JSY
Alpha-Tec Systems, Inc.
Pathology · 16d
Cleared Mar 24, 1988
EPIPACK
K880999 · KIT
Clonetics Corp.
Pathology · 16d
Cleared Mar 24, 1988
NON CONDUCTIVE, SINGLE USE ANESTHESIA FACE MASK
K881067 · BSJ
Medesign, Inc.
Anesthesiology · 10d
Cleared Mar 24, 1988
BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA
K881115 · JSG
Bd Becton Dickinson Vacutainer...
Microbiology · 9d
Cleared Mar 23, 1988
OMNI-VENT, SERIES D
K872113 · CBK
Stein-Gates Medical Equipment, Inc.
Anesthesiology · 296d
Cleared Mar 23, 1988
SDR 3500 (PHILIPS PLATINUM +)
K873937 · IYO
Philips Ultrasound, Inc.
Radiology · 177d
Cleared Mar 23, 1988
LASEGUIDE 600A, 600B, 400A, AND 400B
K874680 · FCS
Laser Peripherals, LLC
Gastroenterology & Urology · 131d
Cleared Mar 23, 1988
IVT WESTERN ALLERGY SCREEN
K875328 · DHB
In Vitro Technologies, Inc.
Immunology · 84d
Cleared Mar 23, 1988
THE DDI SERODOT RUBELLA IGG TEST KIT
K875368 · LFX
Disease Detection International, Inc.
Microbiology · 83d
Cleared Mar 23, 1988
BONE SUTURE FIXATION DEVICE
K880264 · HXY
Orthopedic Systems, Inc.
Orthopedic · 61d