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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
134713–134736 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 15, 1988
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
K882634 · HOX
Vistech Consultants, Inc.
Ophthalmic · 18d
Cleared Jul 15, 1988
MODEL P20/P21 IN-THE-EAR HEARING AID
K882692 · ESD
Maico Hearing Instruments, Inc.
Ear, Nose, Throat · 17d
Cleared Jul 14, 1988
BUBBLE TRAP-FILTER CAT. NO B180F37
K873316 · DTM
American Omni Medical, Inc.
Cardiovascular · 330d
Cleared Jul 14, 1988
H-H FLUSHING RESERVOIR
K875287 · JXG
Holter-Hausner Intl.
Neurology · 198d
Cleared Jul 14, 1988
MTX GENERATOR
K880352 · KPR
Philips Medical Systems (Cleveland),...
Radiology · 170d
Cleared Jul 14, 1988
RESUS-AID
K881065 · CAE
Applied Convergent Technologies, Inc.
Anesthesiology · 122d
Cleared Jul 14, 1988
SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR
K881716 · JWY
Bd Becton Dickinson Vacutainer...
Microbiology · 84d
Cleared Jul 14, 1988
WS 800R THERMAL ARRAY RECORDER
K881831 · DSF
Nihon Kohden America, Inc.
Cardiovascular · 76d
Cleared Jul 14, 1988
MAGNUM 800(TM) MANAGEMENT SYSTEM
K881844 · FNL
The Medical Group, Inc.
General Hospital · 73d
Cleared Jul 14, 1988
RESPIRONICS SUCTIONEASY
K882017 · BSY
Respironics, Inc.
Anesthesiology · 62d
Cleared Jul 14, 1988
MODEL 3000 NUCLEAR CAMERA
K882312 · IYX
Ohio Imaging, Inc.
Radiology · 41d
Cleared Jul 14, 1988
ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL
K882535 · LJC
Abbott Laboratories
Microbiology · 23d
Cleared Jul 14, 1988
LATEX EXAM GLOVES, NON-STERILE
K882583 · FMC
B Und J Instruments
General Hospital · 22d
Cleared Jul 13, 1988
DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
K880322 · KMH
Dentronix, Inc.
General Hospital · 168d
Cleared Jul 13, 1988
CLINICAL ELECTONIC THERMOMETERS
K881368 · FLL
Sheridan Catheter Corp.
General Hospital · 22d
Cleared Jul 13, 1988
CONSEAL COLOSTOMY CONTINENCE SYSTEM (ONE-PIECE)
K881636 · EXB
Coloplast A/S
Gastroenterology & Urology · 90d
Cleared Jul 13, 1988
MODEL 5000 AIR-FLUIDIZED SUPPORT SYSTEM
K881705 · INX
Surgi-Med, Inc.
Physical Medicine · 85d
Cleared Jul 13, 1988
ENTERAL FEEDING TUBES
K881978 · KNT
Primrose Medical, Inc.
Gastroenterology & Urology · 63d
Cleared Jul 13, 1988
POWER EXAMINATION TABLE
K882010 · LGX
Enochs Mfg., Inc.
General Hospital · 61d
Cleared Jul 13, 1988
CLINI-CARE + PRESSURE ULCER TREATMENT SYSTEM
K882092 · FNM
Gaymar Industries, Inc.
General Hospital · 55d
Cleared Jul 13, 1988
VITACUFF(R) PERCUTANEOUS INFECT. CONTROL KIT
K882100 · LJS
Vitaphore Corp.
General Hospital · 55d
Cleared Jul 13, 1988
MR. RAZOR II TWIN
K882388 · LDQ
Burney Products Corp.
General & Plastic Surgery · 33d
Cleared Jul 13, 1988
EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373
K882455 · KDJ
Baxter Healthcare Corp
Gastroenterology & Urology · 29d
Cleared Jul 13, 1988
VAS-CATH PEDIATRIC HEMOFILTRATION CATHETER
K882466 · LFK
Vas-Cath, Inc.
Gastroenterology & Urology · 28d