FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
93409–93432 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 01, 1997
SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP)
K965236 · DSP
Datascope Corp.
Cardiovascular · 182d
Cleared Jul 01, 1997
TWEEZER-TYPE EPILATOR
K970338 · KCX
Igia Direct, Inc.
General & Plastic Surgery · 153d
Cleared Jul 01, 1997
V2
K970481 · LDD
Survivalink Corp.
Cardiovascular · 141d
Cleared Jul 01, 1997
ACCU-PREP
K970484 · KOJ
Bisco, Inc.
Dental · 141d
Cleared Jul 01, 1997
LMI THROMBECTOMY CATHETER
K970657 · DXE
Lucas Medical, Inc.
Cardiovascular · 130d
Cleared Jul 01, 1997
HSV-2 ANTIGEN CONTROL SLIDES
K971101 · GQN
Viral Antigens, Inc.
Microbiology · 97d
Cleared Jul 01, 1997
TRANSEND EX PLATINUM GUIDEWIRE
K971254 · DQX
Boston Scientific Corp
Cardiovascular · 89d
Cleared Jul 01, 1997
OLYMPUS CD-6C-1 COAGULATION ELECTRODE
K971328 · FFE
Olympus America, Inc.
Gastroenterology & Urology · 82d
Cleared Jul 01, 1997
(BRAND NAME)
K971384 · HQY
Long IN Time Ent. Co., Ltd.
Ophthalmic · 78d
Cleared Jul 01, 1997
SUNGLASSES
K971462 · HQY
D.G. Prove Co.
Ophthalmic · 71d
Cleared Jul 01, 1997
SIL-TEC NONREINFORCED SHEETING, REINFORCED SHEETING, RADIOPAQUE SHEETING,...
K971472 · FTL
Technical Products, Inc.
General & Plastic Surgery · 69d
Cleared Jul 01, 1997
RESTRAINTS (VESTS AND JACKETS)
K971536 · FMQ
E.M. Adams Co., Inc.
General Hospital · 64d
Cleared Jul 01, 1997
ULTRASONIC HAND INSTRUMENTS
K971861 · LFL
United States Surgical, A Division of...
General & Plastic Surgery · 42d
Cleared Jun 30, 1997
PC BASED ELECTROCARDIOGRAPH SYSTEM (PC-ECG)
K963578 · DPS
Intl. Products, Inc.
Cardiovascular · 297d
Cleared Jun 30, 1997
DIASCOPE TRAVELLER PLUS (4053)
K964593 · DSI
S & W Medico Teknik A/S
Cardiovascular · 227d
Cleared Jun 30, 1997
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 189d
Cleared Jun 30, 1997
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · JQW
Pharmacia, Inc.
Chemistry · 147d
Cleared Jun 30, 1997
LASERSCOPE MICROBEAM IV MICROMANIPULATOR
K971250 · GEX
Laserscope
General & Plastic Surgery · 90d
Cleared Jun 30, 1997
COULTER ACT TRON CELL CONTROL
K971469 · JPK
Coulter Corp.
Hematology · 69d
Cleared Jun 30, 1997
INNOSENSE PELVIC FLOOR STIMULATION AND ELECTROMYOGRAPHY SYSTEM
K971527 · KPI
Empi
Gastroenterology & Urology · 63d
Cleared Jun 30, 1997
ENDOSSEOUS DENTAL IMPLANT
K971578 · DZE
Straumann USA
Dental · 61d
Cleared Jun 30, 1997
MEDPOR OCULAR SCREW AND ACCEOSSORIES
K971583 · MQU
Porex Technologies Corp.
Ophthalmic · 61d
Cleared Jun 30, 1997
ETEST FOR CEFTAZIDIME
K971694 · JWY
Ab Biodisk
Microbiology · 54d
Cleared Jun 30, 1997
WELCH ALLYN PHACO ILLUMINATOR
K971750 · HQC
Welch Allyn, Inc.
Ophthalmic · 49d