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
101785–101808 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 15, 1995
HI-Q HAND INSTRUMENTS, OB/GYN USE
K944200 · HET
Olympus America, Inc.
Obstetrics & Gynecology · 382d
Cleared Sep 15, 1995
ENDOCYTE TM
K944238 · HCY
D.L. Nelson and Assoc., Inc.
Obstetrics & Gynecology · 380d
Cleared Sep 15, 1995
AES, (ANESCO EVACUATION SYSTEM) ACTIVE WASTE ANESTHETIC GAS EVACUATION SYSTEM
K945216 · CBN
Anesco
Anesthesiology · 325d
Cleared Sep 15, 1995
THE BAGNOLI-2 EMG SYSTEM
K945286 · HCC
Delsys, Inc.
Neurology · 319d
Cleared Sep 15, 1995
AQUAHAB, MODEL 120-72-101
K945733 · BXB
Aquarius Electronics, Inc.
Physical Medicine · 296d
Cleared Sep 15, 1995
DIRECTIONAL CONTROL VALVES INFLATABLE BALLOON-TYPE AND CONTROLLERS
K946077 · BZC
Hans Rudolph, Inc.
Anesthesiology · 276d
Cleared Sep 15, 1995
CONMED VCARE (VAGINAL-CERVICAL AHLUQALIA'S RETRACTOR-ELEVATOR)...
K946220 · LKF
Conmedcorp
Obstetrics & Gynecology · 268d
Cleared Sep 15, 1995
FUKUDA DENSHI MODEL HC-300 END TIDAL CO2 MODULE
K950044 · CCK
Fukuda Denshi USA, Inc.
Anesthesiology · 253d
Cleared Sep 15, 1995
DENTAL IMPLANT ENDOSSEOUS
K950066 · DZE
"O" Co., Inc.
Dental · 249d
Cleared Sep 15, 1995
TOMTECP90
K950279 · LMB
Tomtec Imaging Systems, Inc.
Radiology · 234d
Cleared Sep 15, 1995
APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT
K950382 · JHN
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 15, 1995
APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT
K950383 · JHN
Randox Laboratories, Ltd.
Chemistry · 227d
Cleared Sep 15, 1995
DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K950440 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 231d
Cleared Sep 15, 1995
SULLIVAN PASSOVER HUMIDIFER
K950582 · BTT
Rescare, Inc.
Anesthesiology · 218d
Cleared Sep 15, 1995
UST-5268P-5 TRANSDUCER
K950607 · KRK
Aloka Co., Ltd.
Radiology · 218d
Cleared Sep 15, 1995
HAMEX ONE
K951029 · BXB
Northern Orthopaedic Products, Inc.
Physical Medicine · 192d
Cleared Sep 15, 1995
CARDIO SERV
K951110 · LDD
Hellige GmbH
Cardiovascular · 189d
Cleared Sep 15, 1995
TRANSFEER SPIKE II
K952242 · FPA
The Medi-Dose Group
General Hospital · 126d
Cleared Sep 15, 1995
ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR
K952282 · JIX
Roche Diagnostic Systems, Inc.
Chemistry · 122d
Cleared Sep 15, 1995
GAMBRO LUNDIA 94-700 & SIGMA 800 HEMODIALYZERS
K952342 · KDI
Cobe Renal Care, Inc.
Gastroenterology & Urology · 119d
Cleared Sep 15, 1995
CARDIOLIPIN IGG,M,A EIA TEST KIT
K952520 · MID
Immunoprobe, Inc.
Immunology · 106d
Cleared Sep 15, 1995
SUCTION/IRRIGATOR TUBING KIT
K952605 · GAZ
Surgical Laser Technologies, Inc.
General Hospital · 101d
Cleared Sep 15, 1995
MEDSCAND ENDORETTE ENDOMETRIAL SAMPLER
K952652 · HHK
Medscand (Usa), Inc.
Obstetrics & Gynecology · 98d
Cleared Sep 15, 1995
PAINTED WEDGE & ROD BREAST BOARD
K952729 · IYE
Medtec, Inc.
Radiology · 92d