FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ 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.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93793–93816 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 30, 1997
DOUBLE-HOLE PENCILE-POINT SPINAL NEEDLE (DHPP SPINAL NEEDLE)
K951928 · BSP
Csen , Ltd.
Anesthesiology · 766d
Cleared May 30, 1997
IGA ANTI-GLIADIN (IGA-AGA) ANTIBODY TEST KIT
K964341 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
IGG ANTI-GLIADIN (IGG-AGA) ANTIBODY TEST KIT
K964344 · MST
Immco Diagnostics, Inc.
Immunology · 211d
Cleared May 30, 1997
QUANTA LITE IGG GLIADIN ELISA
K964985 · MST
Inova Diagnostics, Inc.
Immunology · 168d
Cleared May 30, 1997
DUPEL II BUFFERED IONTOPHORESIS ELECTRODES
K970491 · EGJ
Empi
Physical Medicine · 109d
Cleared May 30, 1997
MDX 2000, DIGITAL ANALYZER
K970824 · JOY
Shotwell & Carr, Inc.
Hematology · 85d
Cleared May 30, 1997
QUIKSTRIP ONE STEP AMPHETAMINE TEST
K971218 · DKZ
Drial Consultants, Inc.
Toxicology · 58d
Cleared May 30, 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · JWY
Dade Microscan, Inc.
Microbiology · 46d
Cleared May 30, 1997
LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3
K971691 · DIF
Bio-Rad
Toxicology · 23d
Cleared May 29, 1997
HR12000 ULTRASOUND SYSTEM
K961229 · IYO
International Ultrasound Corp.
Radiology · 426d
Cleared May 29, 1997
SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM
K962142 · IYO
Siemens Medical Solutions USA, Inc.
Radiology · 360d
Cleared May 29, 1997
CTS-285 WITH EZU-PL21 AND EZU-PC3B TRANSDUCERS
K963065 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
CTS-200 WITH EZU-PL21 TRANSDUCER
K963068 · IYO
Shantou Institute of Ultrasonic...
Radiology · 295d
Cleared May 29, 1997
GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES
K963990 · LNH
Philips Medical Systems, Inc.
Radiology · 237d
Cleared May 29, 1997
511 KEV COLLIMATOR
K964438 · KPS
Trionix Research Laboratory, Inc.
Radiology · 205d
Cleared May 29, 1997
QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA(
K964767 · JZG
R&D Systems, Inc.
Immunology · 183d
Cleared May 29, 1997
B2 MICROGLOBULIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITRO DIAGNOSTIC...
K964791 · JZG
Bayer Corp.
Immunology · 181d
Cleared May 29, 1997
ACUPUNCTURE NEEDLES
K964861 · MQX
C.A.M. Supply, Inc.
General Hospital · 176d
Cleared May 29, 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE VANISHPOINT SYRINGE
K970803 · MEG
Retractable Technologies, Inc.
General Hospital · 86d
Cleared May 29, 1997
CARDIAC SCORING FOR CT SCANNERS
K970980 · JAK
Elscint, Inc.
Radiology · 72d
Cleared May 29, 1997
DMA TRIGLYCERIDES PROCEDURES
K971113 · CDT
Data Medical Associates, Inc.
Chemistry · 63d
Cleared May 29, 1997
FRIGIDERM FRIGISPRAY
K971216 · GEH
Dermatologic Lab & Supply, Inc.
General & Plastic Surgery · 57d
Cleared May 29, 1997
CHOL OR CHOLESTEROL
K971345 · CHH
Carolina Liquid Chemistries Corp.
Chemistry · 49d
Cleared May 29, 1997
VARIOLINK II
K971372 · EBF
Ivoclar North America, Inc.
Dental · 45d