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
108289–108312 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared May 13, 1994
PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION
K934722 · KPS
Ohio Imaging, Inc.
Radiology · 226d
Cleared May 13, 1994
WET SENSE
K935915 · KPN
Edson Corp.
Gastroenterology & Urology · 155d
Cleared May 13, 1994
TDA-4000/A4
K941611 · JAA
Toshiba America Medical Systems, In.C
Radiology · 39d
Cleared May 13, 1994
GRIDGIL
K941626 · IXJ
Gilardoni S.P.A.
Radiology · 39d
Cleared May 13, 1994
PHONAK SONO-FORTE 331X BTE HEARING INSTRUMENTS
K941734 · ESD
Phonak, Inc.
Ear, Nose, Throat · 36d
Cleared May 13, 1994
HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808
K941764 · CJY
Hi Chem, Inc.
Chemistry · 45d
Cleared May 12, 1994
SAFE-PICC CATHETER
K930048 · FOZ
Menlo Care, Inc.
General Hospital · 492d
Cleared May 12, 1994
FIXATION PIN
K931697 · HTY
Orthologic Corp.
Orthopedic · 401d
Cleared May 12, 1994
LONZA FORMULATION R-82
K932277 · LRJ
Calgon Vestal Div.
General Hospital · 365d
Cleared May 12, 1994
LONZA FORMULATION R-82
K932502 · LRJ
Lonza, Inc.
General Hospital · 365d
Cleared May 12, 1994
DISPOSABLE SUTURE PLACEMENT SYSTEM
K932553 · GCJ
Laurus Medical Corp.
General & Plastic Surgery · 351d
Cleared May 12, 1994
CLESTRACLEAN(R) ROOM AIR PURIFIER
K932803 · FRA
Clestra Cleanroom Technology, Inc.
General Hospital · 337d
Cleared May 12, 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST. CEMENTED
K932924 · LPH
Implex Corp.
Orthopedic · 331d
Cleared May 12, 1994
LAPAROSCOPIC COVERED SURGICAL RETRACTOR
K933497 · GCJ
Advanced Surgical, Inc.
General & Plastic Surgery · 297d
Cleared May 12, 1994
MORELLE SOS TREATMENT, MORELLE MAMAPLAST, MORELLE ABDOPLAST
K933811 · MDA
Pitt Enterprises (Silicone) , Ltd.
General & Plastic Surgery · 281d
Cleared May 12, 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · DQO
Scimed Life Systems, Inc.
Cardiovascular · 238d
Cleared May 12, 1994
OMNIPULSE MODEL 1210-VHP HO:YAG LASER SYSTEM
K934865 · GEX
Trimedyne, Inc.
General & Plastic Surgery · 212d
Cleared May 12, 1994
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · DTD
Telectronics Pacing Systems, Inc.
Cardiovascular · 210d
Cleared May 12, 1994
WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD
K935403 · DQO
J-Lloyd Medical, Inc.
Cardiovascular · 184d
Cleared May 12, 1994
THE EXPANDACELL SINUS PACK
K935724 · EMX
Denver Splint Co.
Ear, Nose, Throat · 162d
Cleared May 12, 1994
GORE LAPAROSCOPIC SUTURE PASSER
K935986 · GCJ
W.L. Gore & Associates, Inc.
General & Plastic Surgery · 149d
Cleared May 12, 1994
PRESSURE IRRIGATING SYSTEM
K936223 · GCY
Level 1 Technologies, Inc.
General & Plastic Surgery · 134d
Cleared May 12, 1994
RETRACTORS, SPECULUM, CLIP APPLIER FOR TITANIUM CLIPS, 2-WAY STOP COCK,...
K936250 · GCJ
Medicon Instruments, Inc.
General & Plastic Surgery · 133d
Cleared May 12, 1994
ENDOSURG DISPOSABLE SECONDARY TROCAR
K940036 · DRC
Endosurg
Cardiovascular · 128d