Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
161209–161232 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 03, 1982
RHYTHM WHEEL
K813497 · LHD
Tropical Enterprises, Inc.
Obstetrics & Gynecology · 140d
Cleared May 03, 1982
AMS GRAM-POSITIVE IDENTIFICATION CARD
K820264 · JTO
Vitek Systems, Inc.
Microbiology · 90d
Cleared May 03, 1982
BOGER AUTO-TRACTION DEVICE
K820663 · ILZ
D.C. Medical Device, Inc.
Radiology · 54d
Cleared May 03, 1982
DERMA PRENE
K820665 · KGO
Ansell, Inc.
General Hospital · 53d
Cleared May 03, 1982
BANDBAG, WRAP, STERILE
K820692 · MMP
Contour Fabricators, Inc.
General Hospital · 52d
Cleared May 03, 1982
LA VEL LATERAL VIEW EXTENSION LENS
K820732 · HOI
Peter M. Tolliver
Ophthalmic · 47d
Cleared May 03, 1982
MICROBIOLOGY SPECIMEN BRUSH
K820771 · BTG
Mill-Rose Laboratory
Microbiology · 41d
Cleared May 03, 1982
RESPIRATION MONITOR 1000
K820778 · BZQ
Intl. Medical Devices , Ltd.
Anesthesiology · 41d
Cleared May 03, 1982
CANCAN 2002 DENTAL PATIENT CHAIR
K820789
Time Motion System Co.
Dental · 41d
Cleared May 03, 1982
MEDICAM
K820829 · FWB
M.P. Video, Inc.
General & Plastic Surgery · 39d
Cleared May 03, 1982
CONCHO PEDIATRIC PACK
K820878 · BTT
Rci, Inc.
Anesthesiology · 34d
Cleared May 03, 1982
CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI
K820895 · LIN
Bartels Immunodiagnostic Supplies, Inc.
Microbiology · 34d
Cleared May 03, 1982
TECA MODEL SENSOR ER 94
K820908 · GWF
Teca, Inc.
Neurology · 32d
Cleared May 03, 1982
RA-1000 SYSTEM ADD'L ANALYTES PHASE III
K820913 · CEK
Technicon Instruments Corp.
Chemistry · 32d
Cleared May 03, 1982
ROCHE(R) B-HCG RIA URINE STANDARD
K820942 · JHI
Hoffmann-La Roche, Inc.
Chemistry · 27d
Cleared May 03, 1982
SYSTEM I INFANT MONITORING SYS
K820943 · FLS
Burr Engineering & Development Co.
Anesthesiology · 27d
Cleared May 03, 1982
MICROPLATE WASHING DEVICE
K820992 · JTC
Skatron, Inc.
Microbiology · 25d
Cleared May 03, 1982
SALMONELLA & SHIGELLA GROUPING SERA
K820996 · GRL
Fisher Scientific Co., LLC
Microbiology · 24d
Cleared May 03, 1982
ECLIPSE
K821007 · JQW
Scientific Software & Instrument Co.
Chemistry · 24d
Cleared May 03, 1982
ACE ACTIVITY MICROVIAL TEST SET
K821011 · KQN
Ventrex Laboratories, Inc.
Chemistry · 21d
Cleared May 03, 1982
SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL
K821027 · BTR
Shiley, Inc.
Anesthesiology · 20d
Cleared May 03, 1982
NOVA II FLUIDS PACK
K821030 · JIX
Shaban Mfg. Co.
Chemistry · 20d
Cleared May 03, 1982
AMERLEX B-LCG RIA KIT
K821031 · JHI
Amersham Corp.
Chemistry · 20d
Cleared May 03, 1982
MODEL SR-1020LF
K821032 · FPA
Stewart-Riess Labs
General Hospital · 20d