FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
86257–86280 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 19, 1999
AROMAPATCH
K984345 · LRD
Envis, Inc.
Ear, Nose, Throat · 105d
Cleared Mar 19, 1999
NATURAL RUBBER PRE-POWDERED COLORED & FLAVORED PATIENT EXAMINATION GLOVES...
K984449 · LYY
P.T. Irama Dinamika Latex
General Hospital · 95d
Cleared Mar 19, 1999
DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS
K984547 · EWO
Resound Corp.
Ear, Nose, Throat · 87d
Cleared Mar 19, 1999
SILON DUAL-DRESS
K990042 · FRO
Bio Med Sciences, Inc.
General & Plastic Surgery · 72d
Cleared Mar 19, 1999
PAIN CONTROL INFUSION PUMP
K990101 · FRN
Sgarlato Laboratories, Inc.
General Hospital · 66d
Cleared Mar 19, 1999
MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI)
K990134 · JAK
Toshiba America Medical Systems, In.C
Radiology · 64d
Cleared Mar 19, 1999
AUTOMARQER
K990184 · POV
Hamilton Thorne Research
Hematology · 58d
Cleared Mar 19, 1999
EXCITE
K990534 · KLE
Ivoclar North America, Inc.
Dental · 28d
Cleared Mar 19, 1999
SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION
K990563 · MHX
Siemens Medical Solutions USA, Inc.
Cardiovascular · 25d
Cleared Mar 19, 1999
SYMBIOCERAM
K990629 · EIH
Ney Dental, Inc.
Dental · 21d
Cleared Mar 19, 1999
PORTABLE ELECTRIC MOTOR-HANDPIECE UNIT, HANDY-MATE
K990646 · EKX
Nsk Nakanishi, Inc.
Dental · 18d
Cleared Mar 19, 1999
SAS HCG SERUM CONTROLS
K990720 · JJX
Sa Scientific, Inc.
Chemistry · 14d
Cleared Mar 19, 1999
SAS HCG URINE CONTROLS
K990755 · JJX
Sa Scientific, Inc.
Chemistry · 11d
Cleared Mar 18, 1999
PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1
K983336 · LKT
Diagnostic Products Corp.
Microbiology · 176d
Cleared Mar 18, 1999
GILTECH PLUS CONNECTING TUBE SET
K983624 · KDH
Giltech Plus, Inc.
Gastroenterology & Urology · 154d
Cleared Mar 18, 1999
HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM
K983656 · LGC
Zeus Scientific, Inc.
Microbiology · 150d
Cleared Mar 18, 1999
GLUCOMETER ELITE XL BLOOD GLUCOSE METER
K984006 · CGA
Bayer Corp.
Chemistry · 128d
Cleared Mar 18, 1999
ACL/APS FACS KIT
K984102 · MID
Louisville Apl Diagnostics, Inc.
Immunology · 121d
Cleared Mar 18, 1999
CARESIDE LYTES, CARESIDE ANALLYZER MODEL 1000
K990036 · JGS
Careside, Inc.
Chemistry · 71d
Cleared Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML),...
K990296 · GJT
Precision Biologic
Hematology · 49d
Cleared Mar 18, 1999
ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01
K990317 · JJY
Bio-Rad
Chemistry · 48d
Cleared Mar 18, 1999
ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02
K990394 · JJY
Bio-Rad
Chemistry · 37d
Cleared Mar 17, 1999
OSIRIS
K981153 · IYE
Huestis Medical
Radiology · 352d
Cleared Mar 17, 1999
HINGED KNEE
K982160 · KRO
Encore Orthopedics, Inc.
Orthopedic · 271d