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
128425–128448 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 27, 1989
LAP SPONGE
K896801 · EFQ
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d
Cleared Dec 27, 1989
MAGNET PAD
K896802 · LXG
Westmark, Sterile Packing Systems,...
Chemistry · 26d
Cleared Dec 27, 1989
CLOSED WOUND RESERVOIR
K896803 · GCY
Westmark, Sterile Packing Systems,...
General & Plastic Surgery · 26d
Cleared Dec 27, 1989
ALISUN SUNTANNING BED
K896831 · FTC
Alisun America, Ltd.
General & Plastic Surgery · 22d
Cleared Dec 26, 1989
MICROTEK PISTON & WIRE PROSTHESES
K895814 · ETB
Microbio-Medics, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 26, 1989
MICROTEK TOTAL OSSICULAR PROTHESIS
K895815 · ETA
Microbio-Medics, Inc.
Ear, Nose, Throat · 88d
Cleared Dec 26, 1989
RAMVAC DENTAL VACUUM SYSTEM
K895876 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 26, 1989
RAMCLEAN DENTAL VACUUM LINE CLEANER
K895877 · EIA
Ramvac Corp.
Dental · 82d
Cleared Dec 26, 1989
BAUSCH & LOMB FREQUENT REPLACEMENT CASE SYSTEM
K896685 · LRX
Bausch & Lomb, Inc.
Ophthalmic · 28d
Cleared Dec 26, 1989
PLASTIC SUNGLASSES
K896716 · HQY
Bright Horizon Ent.
Ophthalmic · 27d
Cleared Dec 26, 1989
NON-PRESCRIPTION SUNGLASSES
K896768 · HQY
Shairon Intl. Trade Co.
Ophthalmic · 25d
Cleared Dec 22, 1989
VOSS VEIN CLAMP
K885161 · DXC
Voss Medical Products
Cardiovascular · 374d
Cleared Dec 22, 1989
TISSUE OXYGEN MONITOR SYSTEM, MODEL II
K890624 · CCE
Baxter Healthcare Corp
Anesthesiology · 318d
Cleared Dec 22, 1989
SAFE-1
K893704 · DTZ
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Dec 22, 1989
SAFE-1 VENOUS RESERVOIR
K893705 · DTN
Polystan C/O Vitalcor, Inc.
Cardiovascular · 218d
Cleared Dec 22, 1989
FUJITENS III
K893874 · GZQ
Altoona Medical Supply
Neurology · 210d
Cleared Dec 22, 1989
AMBULATORY INFUSION SYSTEM AND ACCESSORIES
K894028 · FRN
Patient Solutions, Inc.
General Hospital · 199d
Cleared Dec 22, 1989
ACTILLUME
K894044 · GWQ
Ambulatory Monitoring, Inc.
Neurology · 198d
Cleared Dec 22, 1989
FIRST IMPRESSION TM
K894282 · ELW
Coe Laboratories, Inc.
Dental · 182d
Cleared Dec 22, 1989
RADIOSCOPE OR MAMMOSCOPE
K894412 · LMA
Vision Ten, Inc.
Radiology · 158d
Cleared Dec 22, 1989
MODEL AO-800PA CO2 MODULE
K894691 · CCK
Nihon Kohden America, Inc.
Anesthesiology · 151d
Cleared Dec 22, 1989
TECA NEUROMAPPER 386
K894889 · OLT
Teca, Inc.
Neurology · 143d
Cleared Dec 22, 1989
CEEGRAPH
K895125 · GWQ
Bio-Logic Systems Corp.
Neurology · 129d
Cleared Dec 22, 1989
MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)
K895555 · CJA
Hichem Diagnostics
Chemistry · 107d