FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
144337–144360 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Apr 09, 1986
LONG TERM RECORDER RAG 1200
K854866 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 152d
Cleared Apr 09, 1986
NUTRIMIX EMPTY CONTAINER
K860042 · KPE
Abbott Laboratories
General Hospital · 93d
Cleared Apr 09, 1986
MEDCO-SONIC NQ-2000
K860099 · IMI
Medco Products, Co., Inc.
Physical Medicine · 89d
Cleared Apr 09, 1986
NITROGLYCERIN INTRAVASCULAR ADMINISTRATION SET
K860157 · FPA
Quest Medical, Inc.
General Hospital · 83d
Cleared Apr 09, 1986
MODEL 900 INFUSION PUMP
K860229 · FRN
C.R. Bard, Inc.
General Hospital · 77d
Cleared Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
K860640 · JQB
Em Diagnostic Systems, Inc.
Chemistry · 48d
Cleared Apr 09, 1986
IV FILTER EXTENSION SET
K860803 · FPB
Med Fusion Systems, Inc.
General Hospital · 36d
Cleared Apr 09, 1986
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
K860838 · BZA
Inspiron Corp.
Anesthesiology · 35d
Cleared Apr 09, 1986
KONTRON CUTANEOUS PO2 MONITOR 820
K860951 · KLK
Kontron Instruments, Inc.
Anesthesiology · 28d
Cleared Apr 09, 1986
GAMMA RADIATION STERILIZED ALCOHOL PREP PADS
K860961 · LKB
H & P Industries, Inc.
General Hospital · 27d
Cleared Apr 09, 1986
DISPOSABLE RESCUE BREATHING DEVICE
K861054 · CAE
B & F Medical Products, Inc.
Anesthesiology · 21d
Cleared Apr 09, 1986
AR-1100 AUTOMATIC REFRACTOR
K861065 · HKO
Nidek, Inc.
Ophthalmic · 20d
Cleared Apr 09, 1986
DISPOSABLE HYPODERMIC NEEDLE SAFETY SHEATH
K861081 · FMI
Perkins & Perkins, Inc.
General Hospital · 19d
Cleared Apr 08, 1986
NIDEK US-1600 A-SCAN
K854389 · IYO
Nidek, Inc.
Radiology · 159d
Cleared Apr 08, 1986
SUPERCATH A.V. FISTULA
K854773 · FIE
Togo Medikit Co., Ltd.
Gastroenterology & Urology · 130d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855097 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
COMPAT ENTERAL DELIVERY SYSTEMS
K855098 · KNT
Sandoz Nutrition
Gastroenterology & Urology · 106d
Cleared Apr 08, 1986
SHAMPAINE RADI-OP MODEL 1700RC
K860620 · KXJ
Smith & Nephew, Inc.
Radiology · 48d
Cleared Apr 08, 1986
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
K860626 · EBF
Scientific Pharmaceuticals, Inc.
Dental · 48d
Cleared Apr 08, 1986
DISPO-URETTE
K860796 · PCF
Roland J. Zwick, Inc.
Obstetrics & Gynecology · 35d
Cleared Apr 08, 1986
MEDCOMP'S FEMORAL VEIN CATHETERS
K860810 · LFK
Medical Components, Inc.
Gastroenterology & Urology · 35d
Cleared Apr 08, 1986
MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM
K860849 · IWB
Marx Pland
Radiology · 33d
Cleared Apr 08, 1986
NORTA TEFLON COATED LATEX BALLOON CATHETERS
K861181 · KOD
Beiersdorf, Inc.
Gastroenterology & Urology · 8d
Cleared Apr 08, 1986
TECNOL SECURE-ALL FETAL MONITOR STRAP
K861189 · HGM
Tecnol New Jersey Wound Care, Inc.
Obstetrics & Gynecology · 8d