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
121729–121752 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 18, 1991
2710-000 OSCILLATING SAW, GENERAL ASSEMBLY
K905383 · GEY
Micro Surgical Instruments Corp.
General & Plastic Surgery · 201d
Cleared Jun 18, 1991
LEVTECH TITANIUM BONE WIRE
K910128 · JDQ
Levtech, Inc.
Orthopedic · 160d
Cleared Jun 18, 1991
LIFE-02 (NON-REFILLABLE CYLINDER)
K910699 · BTL
Life Corp.
Anesthesiology · 119d
Cleared Jun 18, 1991
MANUAL RESUSCITATOR
K910856 · BTM
Vital Signs, Inc.
Anesthesiology · 110d
Cleared Jun 18, 1991
OPHTA SIL(R), ENULCEATION/EVISCERATION IMPLANTS
K911110 · HPZ
G.W.B. Intl., Ltd.
Ophthalmic · 106d
Cleared Jun 18, 1991
MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
K911153 · LCM
Immunotech Corp.
Toxicology · 95d
Cleared Jun 18, 1991
MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS
K911236 · DYB
Medtronic Vascular
Cardiovascular · 90d
Cleared Jun 18, 1991
CERION HAND HELD OXYGEN ANALYZER
K911344 · CCL
Ceramatec, Inc.
Anesthesiology · 83d
Cleared Jun 18, 1991
INFANT VENTILATOR
K911450 · CBK
Preemicare Corp.
Anesthesiology · 85d
Cleared Jun 18, 1991
LUNG DIFFUSION GAS MIXTURES
K911471 · BXK
Norco, Inc.
Anesthesiology · 76d
Cleared Jun 18, 1991
CERAPALL
K911670 · EJS
Metalor Dental USA Corp.
Dental · 68d
Cleared Jun 18, 1991
MAXIBOND
K911757 · EJS
Argen Precious Metals, Inc.
Dental · 61d
Cleared Jun 18, 1991
NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT
K911839 · JLX
Pantex, Div. Bio-Analysis, Inc.
Chemistry · 54d
Cleared Jun 18, 1991
LUER LOCK INJECTION CAP
K911931 · FPA
Dmd Products
General Hospital · 49d
Cleared Jun 18, 1991
AVI MODEL 870 DUAL CHANNEL INFUSION PUMP
K912031 · FRN
3M Avi, Inc.
General Hospital · 41d
Cleared Jun 18, 1991
DISTENDABLE PALPATION PROBE
K912343 · GCJ
Dexide, Inc.
General & Plastic Surgery · 21d
Cleared Jun 17, 1991
TITAN TOTAL HIP DEVICE
K905298 · JDI
Dr. Jean-Marc Guichet
Orthopedic · 202d
Cleared Jun 17, 1991
MUMPS COMPLEMENT-FIXATION (C.F.) ANTIGEN
K905306 · GRC
Virion (U.S.), Inc.
Microbiology · 201d
Cleared Jun 17, 1991
CENTAURI/PEGASUS
K905737 · GEX
Pfizer Laser Systems
General & Plastic Surgery · 175d
Cleared Jun 17, 1991
CAPNOMAC ULTIMA ANESTHESIA MONITOR
K905754 · CBS
Datex Division Instrumentarium Corp.
Anesthesiology · 175d
Cleared Jun 17, 1991
LIFE OXYGENPAC FOR TRAINED MEDICAL PERSONNEL
K910434 · BTL
Life Corp.
Anesthesiology · 137d
Cleared Jun 17, 1991
LIFE OXYGENPAC 6/12 LPM
K910435 · BTL
Life Corp.
Anesthesiology · 137d
Cleared Jun 17, 1991
QM300 CALIBRATOR G PACK
K910885 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d
Cleared Jun 17, 1991
QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK
K910886 · GTQ
Kallestad Diag, A Div. of Erbamont, Inc.
Microbiology · 105d