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
132697–132720 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 28, 1989
N.M.D.C. USER PROTECTIVE HYPODERMIC SYRINGE SYSTEM
K883073 · FMF
National Medical Device Corp.
General Hospital · 223d
Cleared Feb 28, 1989
LIFECARE MICRO PUMP
K883796 · FRN
Abbott Laboratories
General Hospital · 174d
Cleared Feb 28, 1989
INFUSION FLUID WARMER
K883873 · LGZ
Pmt Corp.
General Hospital · 168d
Cleared Feb 28, 1989
MONOPLACE HYPERBARIC EXTENSION SET (L 11055)
K884141 · FPA
Abbott Laboratories
General Hospital · 151d
Cleared Feb 28, 1989
MAGLINTE ENTEROCLYSIS CATHETER
K884379 · FGD
Lafayette Pharmacal, Inc.
Gastroenterology & Urology · 133d
Cleared Feb 28, 1989
EP-100 (SERIES)
K884415 · FPD
Stereotactic Medical Systems, Inc.
Gastroenterology & Urology · 131d
Cleared Feb 28, 1989
ZINETICS(R) EMC
K884527 · KLA
Zinetics Medical, Inc.
Gastroenterology & Urology · 124d
Cleared Feb 28, 1989
DREYER CURVED ENDOILLUMINATOR
K884556 · HQE
Advanced Surgical Products, Inc.
Ophthalmic · 120d
Cleared Feb 28, 1989
NEVISCAN MODEL N - 100
K884989 · HKI
Special Products, Inc.
Hematology · 89d
Cleared Feb 28, 1989
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K884995 · LLZ
Siemens Gammasonics, Inc.
Radiology · 89d
Cleared Feb 28, 1989
SHAPIRO CUTTER
K890544 · HQE
H.S. Intl. Co., Inc.
Ophthalmic · 25d
Cleared Feb 28, 1989
CP&S DISPOSABLE URINARY LEGBAG (MEDIUM & LARGE)
K890550 · KNX
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 28, 1989
URINARY DRAINAGE UNIT
K890551 · KNX
Consolidated Products & Services, Inc.
Gastroenterology & Urology · 22d
Cleared Feb 28, 1989
STICK-GARD SAFETY NEEDLE
K890620 · FMI
Ziehm International, Inc.
General Hospital · 21d
Cleared Feb 28, 1989
ULTIMA WHEELCHAIR CUSHION
K890653 · IMP
Clark Pillow Co., Inc.
Physical Medicine · 20d
Cleared Feb 28, 1989
BARD UMBILICAL VESSEL CATHETER
K890685 · FOS
C.R. Bard, Inc.
General Hospital · 19d
Cleared Feb 27, 1989
DIGICAM LHP (DIGITAL LASER HIGH PERFORMANCE)
K883324 · LMC
Siemens Gammasonics, Inc.
Radiology · 206d
Cleared Feb 27, 1989
TORAY FILTRYZER BK SERIES
K883407 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 200d
Cleared Feb 27, 1989
LAMELLI OXYGEN ENRICHED ENVIRONMENT SYSTEM & TENT
K884018 · CAW
Lamelli Pulmonary Research Center
Anesthesiology · 158d
Cleared Feb 27, 1989
AMPLAID EMG15
K884071 · GWL
Amplus Corp.
Neurology · 153d
Cleared Feb 27, 1989
DACOS OR DACOS XL CLINICAL CHEMISTRY ANALYZER
K884378 · JJE
Coulter Corp.
Chemistry · 132d
Cleared Feb 27, 1989
TCT-600HQ COMPU TOMO(CT)XRAY/HEAD/WHOLE BODY EXAM
K884555 · JAK
Toshiba Medical Systems
Radiology · 119d
Cleared Feb 27, 1989
ACUFEX FIXATION BUTTON
K884565 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 118d
Cleared Feb 27, 1989
MODIFIED FREE T4 RADIOIMMUNOASSAY KIT
K884753 · CEC
Advanced Magnetics, Inc.
Chemistry · 105d