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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
104737–104760 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 24, 1995
PRE-FILLED SYRINGE W/STERILE .25% ACETC ACID
K943835 · KNY
Orion Life Systems, Inc.
Gastroenterology & Urology · 172d
Cleared Jan 24, 1995
3M MODEL 8233 HEARING INSTRUMENT
K943854 · ESD
3M Company
Ear, Nose, Throat · 169d
Cleared Jan 24, 1995
WILSON COOK MULTIPLE BAND LIGATOR
K944220 · MND
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 148d
Cleared Jan 24, 1995
CIT GRASPING AND DISSECTING FORCEPS
K944269 · HET
Chirurgische Instrumente
Obstetrics & Gynecology · 145d
Cleared Jan 24, 1995
KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES
K944793 · KNF
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 118d
Cleared Jan 24, 1995
ARTHROSCOPE
K944842 · HRX
5 Star Medical, Inc.
Orthopedic · 116d
Cleared Jan 24, 1995
KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE
K945100 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 98d
Cleared Jan 24, 1995
DYONICS FIXATION SCREWS
K945182 · HWC
Smith & Nephew Dyonics, Inc.
Orthopedic · 92d
Cleared Jan 24, 1995
DATEMINDER CONTACT LENS CASE
K945259 · LRX
Bruce A. Berkley
Ophthalmic · 88d
Cleared Jan 24, 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576 · EZN
Meadox Medicals, Div. Boston...
Gastroenterology & Urology · 71d
Cleared Jan 24, 1995
VARELISA M2 ANTIBODIES
K945607 · DBM
Elias U.S.A., Inc.
Immunology · 70d
Cleared Jan 24, 1995
SURGILENE(R) SUTURES
K945701 · GAW
Davis & Geck, Inc.
General & Plastic Surgery · 76d
Cleared Jan 24, 1995
PRECISION UV(TM) (VASURFICON A)
K946012 · LPL
Pilkington Barnes-Hind, Ltd.
Ophthalmic · 43d
Cleared Jan 24, 1995
CARDIOSPEX(TM) CKMB/LD-1 IMMUNOINHIBITION CONTROL
K946145 · JJT
Clinical Controls, Inc.
Chemistry · 39d
Cleared Jan 24, 1995
CARDIOSPEX(TM) LIQUID CKMB/LD-1 IMMUNOINHIBITION
K946146 · JJT
Clinical Controls, Inc.
Chemistry · 39d
Cleared Jan 24, 1995
3M(TM) SURGICAL SLIPPER, 9660 SERIES
K946162 · LWK
Wahl Clipper Corp.
General & Plastic Surgery · 36d
Cleared Jan 24, 1995
DUTEX GAUZE BANDAGE
K946326 · EFQ
Dumex Medical Surgical Products, Ltd.
General & Plastic Surgery · 33d
Cleared Jan 20, 1995
TSRH SPINAL SCREWS
K932029 · MNH
Sofamor Danek Mfg., Inc.
Orthopedic · 633d
Cleared Jan 20, 1995
BOLUS DISPENSER
K935811 · FPA
I-Flow Corp.
General Hospital · 414d
Cleared Jan 20, 1995
CANAL KING (THIN) CANAL KING (THICK)
K940368 · KIF
Pulpdent Corp.
Dental · 359d
Cleared Jan 20, 1995
SPECIFIC IGE EIA-ULTRA ASSAY
K941057 · DHB
Hycor Biomedical, Inc.
Immunology · 318d
Cleared Jan 20, 1995
DYNAMEDICS ASAR
K941083 · FNM
Dynamedics Corporation
General Hospital · 318d
Cleared Jan 20, 1995
INNOVA PELVIC FLOOR STIMULATION SYSTEM
K941911 · KPI
Empi
Gastroenterology & Urology · 276d
Cleared Jan 20, 1995
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
K942222 · JCM
Isolab, Inc.
Hematology · 259d