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
102121–102144 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 29, 1995
T4 MICROWELL EIA (ENZYME IMMUNOASSAY0
K950588 · KLI
Biomerica, Inc.
Chemistry · 140d
Cleared Jun 29, 1995
LABORATORY SHARPS BARREL
K950899 · FMI
Biosystems
General Hospital · 122d
Cleared Jun 29, 1995
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD
K951087 · DTB
Pacesetter, Inc.
Cardiovascular · 112d
Cleared Jun 29, 1995
CEDIA FOLATE (NO BOIL) ASSAY
K951155 · CGN
Microgenics Corp.
Chemistry · 107d
Cleared Jun 29, 1995
MODEL PV2000 VASCULAR MICROLABORATORY
K951486 · DPW
Vasamedics, LLC
Cardiovascular · 91d
Cleared Jun 29, 1995
FS-34P2, FIBER SIGMOIDOSCOPE
K951576 · FAM
Pentax Precision Instrument Corp.
Gastroenterology & Urology · 86d
Cleared Jun 29, 1995
SPACEMAKER, II SURGICAL BALLOON DISSECTOR WITH AND WITHOUT A CANNULA
K951878 · GCJ
General Surgical Innovations
General & Plastic Surgery · 84d
Cleared Jun 29, 1995
SYNCHRON ENZYME VALIDATOR SET
K951964 · JIS
Beckman Instruments, Inc.
Chemistry · 63d
Cleared Jun 29, 1995
AXSYM ULTRASENSITIVE HTSH II
K952148 · JLW
Abbott Laboratories
Chemistry · 52d
Cleared Jun 29, 1995
OMNI-JUG
K952200 · KDG
Waterstone Medical, Inc.
General & Plastic Surgery · 50d
Cleared Jun 29, 1995
AESCULAP BIOPOLAR COAGULATOR
K952524 · GEI
Aesculap, Inc.
General & Plastic Surgery · 28d
Cleared Jun 29, 1995
GX-PAN PANORAMIC DENTAL X-RAY SYSTEM
K952598 · GEX
Gendex Corp.
Radiology · 23d
Cleared Jun 28, 1995
3050 DIASCOPE NT PATIENT MONITOR
K942196 · DSI
S & W Medico Teknik A/S
Cardiovascular · 420d
Cleared Jun 28, 1995
PALCO LABS COLD POUCH
K942810 · LDQ
Palco Laboratories, Inc.
General & Plastic Surgery · 378d
Cleared Jun 28, 1995
VECTOR(TM) AMBULATORY DRUG DELIVERY SYSTEM
K943591 · FPA
Infusion Technology Intl.
General Hospital · 338d
Cleared Jun 28, 1995
CAAS II
K945540 · IZI
Pie Medical Equipment B.V.
Radiology · 226d
Cleared Jun 28, 1995
QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH
K945626 · DPS
Quinton, Inc.
Cardiovascular · 224d
Cleared Jun 28, 1995
INTEC FULL FACE SHIELD
K946003 · LYU
Intec Industries, Inc.
General Hospital · 201d
Cleared Jun 28, 1995
MEDISKIN(R) SS, ZENODERM BIOLOGICAL WOUND DRESSING
K950032 · KGN
Brennen Medical, Inc.
General & Plastic Surgery · 175d
Cleared Jun 28, 1995
NORTH BLOODBORNE PATHOGEN RESPONSE KIT
K950554 · FXX
North Safety Products
General Hospital · 145d
Cleared Jun 28, 1995
HORTMANN AIRMATIC AIR CALORIC STIMULATOR
K950785 · KHH
Jedmed Instrument Co.
Ear, Nose, Throat · 127d
Cleared Jun 28, 1995
BELTONE COMPOSER 2000
K950868 · ESD
Beltone Electronics Corp.
Ear, Nose, Throat · 121d
Cleared Jun 28, 1995
SENSICARE SYNTHETIC, SURGICAL GLOVE LINER
K950995 · LYN
Bd Becton Dickinson Vacutainer...
Ear, Nose, Throat · 117d
Cleared Jun 28, 1995
BAZOOKA SYSTEM
K951469 · FNM
Innovative Medical Systems, Inc.
General Hospital · 90d