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
92545–92568 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 11, 1997
MICROJET CAVITY PREPARATION SYSTEM
K964755 · KOJ
Midwest Dental Products Corp.
Dental · 288d
Cleared Sep 11, 1997
HP ORVUE INTRA-OP (M2510A)
K965160 · BSZ
Hewlett-Packard GmbH
Anesthesiology · 262d
Cleared Sep 11, 1997
MICROMARK CLIP
K970817 · GDW
Biopsys Medical, Inc.
General & Plastic Surgery · 189d
Cleared Sep 11, 1997
FINESSE ALL-CERAMIC SYSTEM
K971869 · EIH
Dentsply Intl.
Dental · 113d
Cleared Sep 11, 1997
GETTIG STYRL-JECT DELIVERY SYSTEM
K972285 · EJI
Gettig Pharmaceutical Instrument Co.
Dental · 84d
Cleared Sep 11, 1997
BIOZ SYSTEM & BIOZ PORTABLE
K972320 · DSB
Cardiodynamics International Corp.
Cardiovascular · 80d
Cleared Sep 11, 1997
KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL)
K972380 · LMB
Eastman Kodak Company
Radiology · 77d
Cleared Sep 11, 1997
ROOT APEX LOCATOR
K972407 · LQY
Toei Electric Co., Ltd.
Dental · 77d
Cleared Sep 11, 1997
ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM
K972435 · JDI
Johnson & Johnson Professionals, Inc.
Orthopedic · 73d
Cleared Sep 11, 1997
CEILING MOUNTED LATERAL POSITIONER, MODEL NO. 6896.002
K972442 · JAA
Continental X-Ray Corp.
Radiology · 73d
Cleared Sep 11, 1997
ALTA PLATING SYSTEM
K972479 · HRS
Howmedica Corp.
Orthopedic · 72d
Cleared Sep 11, 1997
BREATH-SO-FRESH TONGUE CLEANER
K972644 · LCN
Intl. Dental Design Specialists, Inc.
Dental · 58d
Cleared Sep 11, 1997
TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
K972666 · CIN
Hybritech, Inc.
Chemistry · 57d
Cleared Sep 10, 1997
COSMED K4
K963373 · BZC
Cosmed Srl
Anesthesiology · 379d
Cleared Sep 10, 1997
MODEL CG-2206 PERSONAL ELECTROCARDIOGRAM (ECG) TRANSMITTER DEVICE (MODIFIED)
K963725 · DXH
Card Guard , Ltd.
Cardiovascular · 415d
Cleared Sep 10, 1997
HTP-1500 LOCALIZED HEAT THERAPY PUMP
K970197 · ILO
Adroit Medical Systems, Inc.
Physical Medicine · 232d
Cleared Sep 10, 1997
IMPULSE HVG
K970847 · IPF
Armstrong Industries, Inc.
Physical Medicine · 187d
Cleared Sep 10, 1997
NARKOMED M ANESTHESIA SYSTEM (M)
K971425 · BSZ
Draeger Medical, Inc.
Anesthesiology · 146d
Cleared Sep 10, 1997
VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
K971494 · GNX
Zymetx, Inc.
Microbiology · 139d
Cleared Sep 10, 1997
S3 CYCLIC RPM CONTROL
K971520 · DWB
Stoeckert Instrumente
Cardiovascular · 138d
Cleared Sep 10, 1997
BIOCOR SOFTSHELL VENOUS RESERVOIR (BIOCOR SVR)
K972017 · DTN
Minntech Corp.
Cardiovascular · 103d
Cleared Sep 10, 1997
MULTIDOS, QC6PLUS
K972211 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
0.015CC PINPOINT IONIZATION CHAMBER, 0.005 CC PINPOINT IONIZATION CHAMBER
K972212 · LHN
Ptw-New York Corp.
Radiology · 90d
Cleared Sep 10, 1997
BONE PLATE WITH CABLES
K972223 · HRS
Pioneer Surgical Technology
Orthopedic · 89d