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
132193–132216 of 175,820
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 07, 1989
DC-4 SHUNT INFUSION T
K891754 · FKB
Akcess Medical Products, Inc.
Gastroenterology & Urology · 15d
Cleared Apr 07, 1989
FC-100 FEMORAL CATHETER
K891763 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 07, 1989
FC-101 FEMORAL CATHETER GUIDE WIRE
K891764 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 14d
Cleared Apr 06, 1989
TSRH SACRAL SPINAL SCREW
K883783 · KWP
Warsaw Orthopedic, Inc.
Orthopedic · 212d
Cleared Apr 06, 1989
TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE
K883784 · LYQ
Warsaw Orthopedic, Inc.
Orthopedic · 212d
Cleared Apr 06, 1989
KATZEN THROMBOLYSIS GUIDEWIRE
K883880 · DQX
Medi-Tech, Inc.
Cardiovascular · 205d
Cleared Apr 06, 1989
PHACOEMULSIFIER MODEL 100
K890080 · HQC
Sonic Needle Corp.
Ophthalmic · 87d
Cleared Apr 06, 1989
DEVILBISS MODEL 1400D (OXYGEN CONSERVING DEVICE)
K890141 · NFB
Devilbiss Health Care, Inc.
Anesthesiology · 83d
Cleared Apr 06, 1989
C-S IMPACTOR
K890185 · LYP
Orthopedic Systems, Inc.
Orthopedic · 78d
Cleared Apr 06, 1989
THE C-S DISTRACTION ROD ASSEMBLY
K890187 · KWP
Orthopedic Systems, Inc.
Orthopedic · 78d
Cleared Apr 06, 1989
LATEX EXAMINATION GLOVES NON-STERILE
K890356 · LYY
Quest Intl., Inc.
General Hospital · 72d
Cleared Apr 06, 1989
VINYL PATIENT EXAMINATION GLOVE
K890987 · LYZ
Jm Gloves Co., Ltd.
General Hospital · 36d
Cleared Apr 06, 1989
PATIENT EXAMINATION GLOVE
K891017 · LYY
Paramount Products, Inc.
General Hospital · 37d
Cleared Apr 06, 1989
KIRSCHNER RETRACTOR
K891031 · GAD
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 37d
Cleared Apr 06, 1989
COOL 'N HEAT MACHINE
K891151 · ILO
Kinetic Concepts, Inc.
Physical Medicine · 34d
Cleared Apr 06, 1989
MEDI-TRACE THERMAL VIDEO FILM PAPER
K891192 · LMD
Graphic Controls Corp.
Radiology · 31d
Cleared Apr 06, 1989
RIBBON TYPE SCISSORS: TENOTOMY,IRIS,EYE,STRABISMUS
K891200 · LRW
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 31d
Cleared Apr 06, 1989
SCISSORS: THOREK, JORGENSEN, FINOCHIETTO
K891203 · LRW
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 31d
Cleared Apr 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891260 · LYY
The Glove Outlet, Inc.
General Hospital · 29d
Cleared Apr 06, 1989
MICRO CAUTERY NEEDLES
K891400 · JOS
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 23d
Cleared Apr 06, 1989
HEMOSTATIC FORCEPS BRUNS.,GEMINI,SPENCER-WELL,KANT
K891401 · GEN
Zinnanti Surgical Instruments, Inc.
General & Plastic Surgery · 23d
Cleared Apr 06, 1989
SURGILASE YAG 100 SURGICAL ND:YAG LASER/GEN SURG
K891461 · GEX
Surgilase, Inc.
General & Plastic Surgery · 22d
Cleared Apr 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891507 · LYY
Purna Bina Sdn Bhd
General Hospital · 21d
Cleared Apr 06, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891508 · LYY
Safeway Products, Inc.
General Hospital · 21d