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
133969–133992 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 03, 1988
PREMIER DECANNULATION STOPPER
K884015 · BTO
Premier Dental
Anesthesiology · 42d
Cleared Nov 03, 1988
COHERENT EXCELITE CO2 AIR FIBER
K884204 · GEX
Coherent Medical Lasers
General & Plastic Surgery · 28d
Cleared Nov 03, 1988
NOVAPATH SPECIMEN COLLECTION KIT
K884342 · LIO
Bio-Rad
Microbiology · 20d
Cleared Nov 02, 1988
ACCUTEMP(TM) TEMP. MONITIORING SYSTEM SWALLOWABLE
K880639 · FLL
Human Technologies, Inc.
General Hospital · 260d
Cleared Nov 02, 1988
MODEL IDS640 PATIENT DATA DISPLAY & STORAGE MONIT.
K882352 · CCL
Clinical Information Systems, Inc.
Anesthesiology · 148d
Cleared Nov 02, 1988
HEALTH-WATCH BED MONITOR
K882377 · BZQ
Engineering Developments, Co.
Anesthesiology · 147d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR105
K882951 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 111d
Cleared Nov 02, 1988
CO2 SURGICAL LASER SYSTEM MODEL #IR106
K882952 · GEX
Niic U.S.A., Inc.
General & Plastic Surgery · 111d
Cleared Nov 02, 1988
TS1000 SUCTION TIP
K883384 · BSY
M.D. Engineering, Inc.
Anesthesiology · 85d
Cleared Nov 02, 1988
OXYTROL
K883590 · NFB
Cryogenic Assoc.
Anesthesiology · 72d
Cleared Nov 02, 1988
MARK-5 CONCENTRATOR
K883591 · CAW
Nidek Medical Products, Inc.
Anesthesiology · 71d
Cleared Nov 02, 1988
TYPE 9230 TEMP 1 & 2 SYSTEM ATHENA
K884119 · FLL
S & W Medico Teknik
General Hospital · 33d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR PREALBUMIN
K884297 · JZJ
Atlantic Antibodies
Immunology · 21d
Cleared Nov 02, 1988
SPQ(TM) TEST SYSTEM FOR MICROALBUMIN
K884298 · JZJ
Atlantic Antibodies
Immunology · 21d
Cleared Nov 02, 1988
FOME-CUF TRACHEAL TUBES W/SIDEPORT AIRWAY CONNECT.
K884427 · BTO
Bivona Medical Technologies
Anesthesiology · 13d
Cleared Nov 01, 1988
CARBON DIOXIDE ASSAY KIT (ENZYMATIC) 201-18/202-18
K880868 · KHS
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 245d
Cleared Nov 01, 1988
MSI STANDARD BED MODELS L1098-84/L1098-74/L1085-74
K881960 · FNL
Med Service, Inc.
General Hospital · 175d
Cleared Nov 01, 1988
MSI STANDARD BED MODELS: L1097-64 AND L1085-64
K881961 · FNJ
Med Service, Inc.
General Hospital · 175d
Cleared Nov 01, 1988
250 ML BAG W/Y INJECT. & 12 EXTENSION SET
K882598 · FRN
Prn Services, Inc.
General Hospital · 130d
Cleared Nov 01, 1988
TYMPANIC TEMPERATURE SCANNER
K882949 · FLL
Omega Medical Corp.
General Hospital · 110d
Cleared Nov 01, 1988
Q4000 OPTION FOR Q4000
K882978 · DSI
Quinton, Inc.
Cardiovascular · 109d
Cleared Nov 01, 1988
IRRIGATION SET
K883300 · HRX
Edwards Orthopaedics Div., Baxter...
Orthopedic · 89d
Cleared Nov 01, 1988
EP-100 INFUSION PUMP
K883653 · FRN
Stereotactic Medical Systems, Inc.
General Hospital · 67d
Cleared Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
K883688 · GJT
Ortho Diagnostic Systems, Inc.
Hematology · 64d