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
116785–116808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jun 30, 1992
BLOM-SINGER HUMID/FIL SYST INHEALTH IN-LINE HUMID.
K915786 · BYD
Helix Medical, Inc.
Anesthesiology · 189d
Cleared Jun 30, 1992
ORWO X-RAY FILM
K920539 · IWZ
Burkhart Roentgen Intl., Inc.
Radiology · 146d
Cleared Jun 30, 1992
RX 90 ACETABULAR COMPONENT SYSTEM
K920639 · JDI
Biomet, Inc.
Orthopedic · 139d
Cleared Jun 30, 1992
FULL HEMISPHERE RING-LOC LINER
K920640 · JDI
Biomet, Inc.
Orthopedic · 139d
Cleared Jun 30, 1992
VFC UNIT
K920746 · JAA
Tilane Corp.
Radiology · 132d
Cleared Jun 30, 1992
INTEGRATED ENDOSCOPY SYSTEM 1000
K920800 · HRX
Biomet, Inc.
Orthopedic · 130d
Cleared Jun 30, 1992
NUTRIMIX MICROCOMPOUNDER
K921365 · LHI
Abbott Laboratories
General Hospital · 102d
Cleared Jun 30, 1992
IOLAB REUSABLE PERISTATIC CASSETTE/OPHTHALMIC USE
K921607 · HQC
Chiron Vision Corp.
Ophthalmic · 88d
Cleared Jun 30, 1992
DISPOSABLE VOLUME VENT/ANESTHESIA BREATH CIRCUITS
K921624 · BYH
Intertech Resources, Inc.
Anesthesiology · 85d
Cleared Jun 30, 1992
BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER
K921661 · JJE
Boehringer Mannheim Corp.
Chemistry · 84d
Cleared Jun 30, 1992
RNA MEDICAL'S EQUIL 55
K922357 · JJS
Bionostics, Inc.
Chemistry · 42d
Cleared Jun 30, 1992
WIDEX MODEL D32
K922708 · ESD
Widex Hearing Aid Co., Inc.
Ear, Nose, Throat · 25d
Cleared Jun 29, 1992
NEEDLECRIC
K914471 · JOH
Ajs Medical Co., Inc.
Anesthesiology · 265d
Cleared Jun 29, 1992
GEL-TAC
K915328 · DRO
Katecho, Inc.
Cardiovascular · 216d
Cleared Jun 29, 1992
SHERPA GUIDING CATHETER WITH CATHETER INTRODUCER
K915351 · DQO
Medtronics Interventional Vascular
Cardiovascular · 216d
Cleared Jun 29, 1992
WECK TROCAR
K915378 · HET
Edward Weck, Inc.
Obstetrics & Gynecology · 213d
Cleared Jun 29, 1992
BIVONA-COLORADO VOICE PROSTHESIS
K915761 · EWL
Bivona Medical Technologies
Ear, Nose, Throat · 188d
Cleared Jun 29, 1992
POWERED VACUUM ASPIRATOR 1110-G-030
K920287 · JCX
Stirn Industries
General & Plastic Surgery · 159d
Cleared Jun 29, 1992
POWERED VACUUM ASPIRATOR 1110-G-062
K920288 · JCX
Stirn Industries
General & Plastic Surgery · 159d
Cleared Jun 29, 1992
IVOS ANALYZER
K920719 · GKL
Hamilton Thorne Research
Hematology · 132d
Cleared Jun 29, 1992
CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V)
K921465 · GKP
Helena Laboratories
Hematology · 94d
Cleared Jun 29, 1992
MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM
K921556 · LJZ
Medical Diagnostic Technologies, Inc.
Microbiology · 89d
Cleared Jun 29, 1992
COXSACKIE VIRUS B1-B6 CF ANTIGENS
K921618 · GNG
Virion (U.S.), Inc.
Microbiology · 84d
Cleared Jun 29, 1992
TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093
K921700 · JLW
Medix Biotech, Inc.
Chemistry · 82d