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
99721–99744 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Dec 11, 1995
ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM
K944612 · LLZ
Codman & Shurtleff, Inc.
Radiology · 448d
Cleared Dec 11, 1995
BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES
K946249 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 353d
Cleared Dec 11, 1995
HAMEX TWO
K951028 · BXB
Northern Orthopaedic Products, Inc.
Physical Medicine · 279d
Cleared Dec 11, 1995
AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
K951494 · CIJ
Emd Chemicals, Inc.
Chemistry · 255d
Cleared Dec 11, 1995
OCTOSTIM
K951682 · IPF
Freiler
Physical Medicine · 244d
Cleared Dec 11, 1995
VERSA-VU
K951898 · HIB
CooperSurgical, Inc.
Obstetrics & Gynecology · 231d
Cleared Dec 11, 1995
HUMAC SYSTEM
K952090 · IKK
Computer Sports Medicine, Inc.
Physical Medicine · 222d
Cleared Dec 11, 1995
SCINITREX BLUE POWDERED NITRILE EXAMINATION GLOVES
K952155 · LZA
Wembley Rubber Products (M) Sdn Bhd
General Hospital · 217d
Cleared Dec 11, 1995
JANUS I
K952551 · IYO
3D Ultrasound, Inc.
Radiology · 192d
Cleared Dec 11, 1995
ACS PHENOBARBITAL
K953021 · DIS
Ciba Corning Diagnostics Corp.
Toxicology · 165d
Cleared Dec 11, 1995
BLOODBORNE PATHOGEN KIT
K953102 · FXX
Certified Safety Mfg., Inc.
General Hospital · 161d
Cleared Dec 11, 1995
METRO 55G TORIC & SPHERICAL
K953199 · LPL
Metrosoft, Inc.
Ophthalmic · 154d
Cleared Dec 11, 1995
HDL PRECIPITATING REAGENT
K954179 · LBR
Schiapparelli Biosystems, Inc.
Chemistry · 96d
Cleared Dec 11, 1995
MASSAGER THERAPUTIC, ELECTRIC
K954203 · IRO
Cisco Sales Corp.
Physical Medicine · 95d
Cleared Dec 11, 1995
POWDER FREE LATEX EXAMINATION GLOVES
K954365 · LYY
Perusahaan Getah Asas Sdn. Bhd.
General Hospital · 84d
Cleared Dec 11, 1995
SHANGHAI POSEDON PLASTIC PRODUCTS VINYL EXAM GLOVES
K954381 · LYZ
Shanghai Poseidon Plastic Products...
General Hospital · 83d
Cleared Dec 11, 1995
A-B ACETABULAR COMPONENT
K954417 · LPH
Biomet, Inc.
Orthopedic · 81d
Cleared Dec 11, 1995
ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES
K954533 · LZA
Eci Medical Technologies, Inc.
General Hospital · 73d
Cleared Dec 11, 1995
ELASTYREN HYPOALLERGENIC SURGICAL GLOVES
K954535 · KGO
Eci Medical Technologies, Inc.
General Hospital · 73d
Cleared Dec 11, 1995
MODEL D-285N ADMINISTRATION SET
K954841 · FPA
Patient Solutions, Inc.
General Hospital · 49d
Cleared Dec 11, 1995
BIONIKE A/Q PREGNANCY TEST
K954901 · JHI
Bionike Laboratories, Inc.
Chemistry · 47d
Cleared Dec 11, 1995
ACETAL DENTAL/PREFORMED CLASP
K954971 · EHP
B & H Technical Services , Ltd.
Dental · 45d
Cleared Dec 11, 1995
OPTIBOND 2A PRECOAT
K955068 · EMA
Sybron Dental Specialties, Inc.
Dental · 35d
Cleared Dec 11, 1995
OPTIBOND
K955070 · EIH
Optimal Dental (Usa)
Dental · 35d