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
101785–101808 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 21, 1995
TRU-PULSE PULSED CO2 SURGICAL LASER SYSTEM
K952049 · GEX
Tissue Technologies, Inc.
General & Plastic Surgery · 81d
Cleared Jul 21, 1995
SAS BRUCELLA AMS ANTISERUM
K952132 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS SALMONELLA O POLY POSITIVE ANTISERUM
K952133 · GRM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS SALMONELLA H POLY POSITIVE ANTISERUM
K952134 · GRM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS FRANCISELLA TULARENSIS ANTISERUM
K952141 · GSK
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS BRUCELLA MELITENSIS ANTISERUM
K952143 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS BRUCELLA SUIS ANTISERUM
K952144 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
SAS BRUCELLAS ABORTUS ANTISERUM
K952146 · GSM
Sa Scientific, Inc.
Microbiology · 74d
Cleared Jul 21, 1995
VITALOCK SOLID BACKED ACETABULAR SHELL
K952397 · LPH
Howmedica Corp.
Orthopedic · 60d
Cleared Jul 21, 1995
CELSITE VENOUS SYSTEM
K952548 · LJT
B.Braun Medical, Inc.
General Hospital · 49d
Cleared Jul 21, 1995
MWCHAC 95 C 12345
K952820 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jul 21, 1995
MWCHAC 95 FS 12345
K952821 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 31d
Cleared Jul 21, 1995
DB PUSH-PULL HEARING AID
K953036 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 32d
Cleared Jul 21, 1995
DYNAMIC EQ/CLASS D
K953038 · ESD
Midwest City Hearing Aid Center
Ear, Nose, Throat · 32d
Cleared Jul 20, 1995
GASTRANIMAL PERCUTANEOUS REPLACEMENT GASTROOMY
K923488 · KNT
Applied Medical Technologies
Gastroenterology & Urology · 1100d
Cleared Jul 20, 1995
VINYL PATIENT EXAMINATION GLOVES
K941809 · LYZ
Cheer & Merit Co., Ltd.
General Hospital · 464d
Cleared Jul 20, 1995
HEALTH IMAGES, INC. HI-STANDARD
K944228 · LNH
Health Images, Inc.
Radiology · 323d
Cleared Jul 20, 1995
AUTOFLO INTRA-OP SHED BLOOD AUTORTRANSFUSTION SYS
K944232 · CAC
Haemonetics Corp.
Anesthesiology · 322d
Cleared Jul 20, 1995
FEMOSTOP II
K944259 · DXC
Radi Medical Systems AB
Cardiovascular · 322d
Cleared Jul 20, 1995
SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM
K945700 · KWQ
Synthes (Usa)
Orthopedic · 246d
Cleared Jul 20, 1995
ABSOGEL NON-STERILE EXAMINATION GLOVES (POWDER-FREE)
K946056 · LYY
Ampri Rubberware Industries Sdn Bhd
General Hospital · 226d
Cleared Jul 20, 1995
COULTER MH025A
K950949 · GKZ
Coulter Corp.
Hematology · 140d
Cleared Jul 20, 1995
KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR...
K951394 · HET
KARL STORZ Endoscopy-America, Inc.
Obstetrics & Gynecology · 114d
Cleared Jul 20, 1995
LUMIX 70B
K951734 · EAP
Emix U.S.A., Inc.
Radiology · 97d