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

Filters: Cleared only ×
175,820 results
126601–126624 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 09, 1990
NDM SWITCHPEN HOLSTER
K901145 · GEI
Ndm Corp.
General & Plastic Surgery · 58d
Cleared May 09, 1990
PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE
K901332 · DTC
Biotronik, GmbH & Co.
Cardiovascular · 48d
Cleared May 09, 1990
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · DRQ
C.R. Bard, Inc.
Cardiovascular · 47d
Cleared May 09, 1990
GABRIEL MEDICAL CLS THERMAL RECORDER
K901385 · DSF
Gabriel Medical, Inc.
Cardiovascular · 44d
Cleared May 09, 1990
ANEROID SPHYGMOMANOMETER, DOCTOR TYPE
K901506 · DXQ
Yamasu Co. , Ltd.
Cardiovascular · 40d
Cleared May 09, 1990
READS(R) ANTI-ENA (SM/RNP) TEST KIT
K901924 · LLL
Biosearch Medical Products, Inc.
Immunology · 9d
Cleared May 09, 1990
SURGICAL RETENTION BAR
K902001 · KGS
Acufex Microsurgical, Inc.
General & Plastic Surgery · 7d
Cleared May 07, 1990
VITAJET(INSULIN JET INJECTION DEVICE)
K893215 · KZE
Vitajet Industriae Comercioltda.
General Hospital · 375d
Cleared May 07, 1990
HPI ORTHO SURGEONS' GLOVE
K894828 · KGO
Tillotson Rubber Co., Inc.
General Hospital · 280d
Cleared May 07, 1990
THERMO-5000
K895358 · LHQ
Medtronix Ltd., Inc.
Radiology · 252d
Cleared May 07, 1990
FERMIT TEMPORARY MATERIAL
K896530 · EBF
Ivoclar North America, Inc.
Dental · 174d
Cleared May 07, 1990
PERLINK CASSETTE, KIRAN CASSETTE
K896708 · IXA
Perlink USA, Inc.
Radiology · 160d
Cleared May 07, 1990
ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM
K896755 · IYO
Ge Medical Systems Information...
Radiology · 157d
Cleared May 07, 1990
COATED NOVAFIL, POLYBUTESTER, MESH
K896946 · FTM
American Cyanamid Co.
General & Plastic Surgery · 145d
Cleared May 07, 1990
CU-75 VISIBLE LIGHT-CURING UNIT
K900135 · EBZ
Kab Gloves Unltd.
Dental · 117d
Cleared May 07, 1990
MTHF-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT
K900194 · OXO
Imt America, Inc.
Radiology · 111d
Cleared May 07, 1990
UNITY DENTAL CEMENT
K900342 · EMA
Whaledent Intl. Div. Ipco
Dental · 104d
Cleared May 07, 1990
THERMOAIRE SPLINT (TM) (TAS)
K900356 · ILO
Life Enhancement Technologies, LLC
Physical Medicine · 102d
Cleared May 07, 1990
MODIFIED STERILIZATION OF DRILLS, BURRS, TREPHINES
K900388 · HBE
Midas Rex Pneumatic Tools, Inc.
Radiology · 98d
Cleared May 07, 1990
DISP. ELECTROSURGERY PENCIL, HAND CONTROL
K900633 · GEI
Medical/Surgical Specialties, Ltd.
General & Plastic Surgery · 88d
Cleared May 07, 1990
TS-1800 MEDICATION TRANSFER SPIKE
K900651 · FPA
The Medi-Dose Group
General Hospital · 87d
Cleared May 07, 1990
STEEROCATH(TM)
K900765 · DRF
Ep Technologies, Inc.
Cardiovascular · 80d
Cleared May 07, 1990
OTT INSUFFLATION FILTER TUBING
K900878 · HIF
Gynescope Corp.
Obstetrics & Gynecology · 70d
Cleared May 07, 1990
AMCATH SUCTION-IRRIGATION TUBE
K900988 · HET
Intl. Medical, Inc.
Obstetrics & Gynecology · 66d