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
135049–135072 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 03, 1988
MEDIBLEND (TM) MEDICAL LASER GAS MIXTURES
K882208 · GEX
Linde Div. Union Carbide Corp.
General & Plastic Surgery · 69d
Cleared Aug 03, 1988
STERILE DISPOSABLE SURGICAL GOWNS
K882470 · FYA
Bolden Products, Div. of the...
General Hospital · 49d
Cleared Aug 03, 1988
THREE-COMPONENT MEDICAL LASER GAS MIXTURES
K882516 · GEX
Matheson Gas Products, Inc.
General & Plastic Surgery · 44d
Cleared Aug 03, 1988
REPAK SURGICAL PACKS - GOWN/TOWEL/MAJOR/DRAPE/BAS.
K882684 · LRO
Standard Textile Co., Inc.
General & Plastic Surgery · 34d
Cleared Aug 03, 1988
GAUZE PACKING, X-RAY DETECTABLE
K882707 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
GAUZE SPONGE, X-RAY DETECTABLE
K882708 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
TONSIL SPONGE, X-RAY DETECTABLE, W/STRING
K882709 · GDY
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
INTESTINAL SPONGES
K882710 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
GAUZE SPONGE 12PLY
K882711 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
STICK SPONGE
K882712 · EFQ
Bioseal
General & Plastic Surgery · 37d
Cleared Aug 03, 1988
MICROTEK PROBE DRAPE
K882724 · KKX
Microbio-Medics, Inc.
General Hospital · 33d
Cleared Aug 03, 1988
VITAL-VUE ILLUMINATION, SUCTION AND IRRIGATION
K882956 · HBI
Vital Metrics, Inc.
General & Plastic Surgery · 21d
Cleared Aug 03, 1988
AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER
K883018 · FZP
United States Surgical, A Division of...
General & Plastic Surgery · 15d
Cleared Aug 03, 1988
STORZ MICROSURGICAL BIPOLAR COAGULATOR
K883060 · GEI
Storz Instrument Co.
General & Plastic Surgery · 15d
Cleared Aug 02, 1988
OMNIGRAPH 6000
K880357 · DPS
Telemed Div.
Cardiovascular · 187d
Cleared Aug 02, 1988
CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES
K880575 · LDD
Nihon Kohden America, Inc.
Cardiovascular · 174d
Cleared Aug 02, 1988
SIEMENS INTRAVAGINAL TRANSDUCER
K881405 · HGL
Siemens Medical Solutions USA, Inc.
Obstetrics & Gynecology · 120d
Cleared Aug 02, 1988
SYSTEM5RH STATIONARY EXERCISE BICYCLE
K881475 · DPS
Combi Co. Ltd., C/O Mitsui & Co....
Cardiovascular · 117d
Cleared Aug 02, 1988
CATHETER STRAP
K881781 · KOD
Baxter Healthcare Corp
Gastroenterology & Urology · 98d
Cleared Aug 02, 1988
QLT ABSOLUTE URINE-HCG PREGNANCY TEST
K881806 · JHI
Quadra Logic Technologies, Inc.
Chemistry · 96d
Cleared Aug 02, 1988
MODEL MICRO SI AMBULATORY ECG MONITOR
K881905 · DSI
Advanced Medical Products, Inc.
Cardiovascular · 88d
Cleared Aug 02, 1988
EMIT HVA OPIATE ASSAY
K881941 · DJG
Syva Co.
Toxicology · 85d
Cleared Aug 02, 1988
ASSIST(TM) ASEPTIC SYRINGE IRRIGATION SYSTEM
K881981 · KOD
Ryder Intl. Corp.
Gastroenterology & Urology · 82d
Cleared Aug 02, 1988
MODIFICATION OF BEHRING RAPIMAT II/T
K882095 · JJQ
Behring Diagnostics, Inc.
Chemistry · 75d