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
107089–107112 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Aug 02, 1994
AMMONIA ASSAY CAT. NO. 200-02
K932556 · JIF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 433d
Cleared Aug 02, 1994
VIDAS CMV IGM ASSAY
K933549 · LKQ
Biomerieux Vitek, Inc.
Microbiology · 376d
Cleared Aug 02, 1994
MINIOX IA OXYGEN ANALYZER
K935370 · CAW
Minesafety Appliances Co.
Anesthesiology · 271d
Cleared Aug 02, 1994
THAIRAPY SYSTEM
K936121 · BYI
American Biosystems, Inc.
Anesthesiology · 222d
Cleared Aug 02, 1994
DIAGNOSTIC I CATHETER
K940167 · DRF
Ep Technologies, Inc.
Cardiovascular · 207d
Cleared Aug 02, 1994
INCSTAR ACTH IRMA
K940271 · CKG
Incstar Corp.
Chemistry · 193d
Cleared Aug 02, 1994
DENTIST WITH ASSISTANT PACK
K940864 · EIA
Sterile Concepts, Inc.
Dental · 160d
Cleared Aug 02, 1994
UMBILI-CATH
K940870 · FOS
Gesco Intl., Inc.
General Hospital · 158d
Cleared Aug 02, 1994
MICROTAINER BRAND TUBE WITH EDTA(K2)
K940905 · JKA
Bd Becton Dickinson Vacutainer...
Chemistry · 159d
Cleared Aug 02, 1994
UMBILI-CATH-S
K940953 · FOS
Gesco Intl., Inc.
General Hospital · 154d
Cleared Aug 02, 1994
STREP-SURE A/E
K941111 · JTO
Clinical Standards Laboratories, Inc.
Microbiology · 148d
Cleared Aug 02, 1994
KLEENSPEC
K941272 · HIB
Welch Allyn, Inc.
Obstetrics & Gynecology · 139d
Cleared Aug 02, 1994
HI CHEM AQUEOUS GLUCOSE CONTROL, LOW, MED, HIGH
K941433 · JJX
Hichem Diagnostics
Chemistry · 131d
Cleared Aug 02, 1994
BIOCALEX 6/9
K941532 · EJK
Bio-Probe, Inc.
Dental · 125d
Cleared Aug 02, 1994
SUNGLASSES
K941540 · HQY
Tonview International Co., Ltd.
Ophthalmic · 125d
Cleared Aug 02, 1994
SUNGLASSES
K941929 · HQY
Top Champ, Inc.
Ophthalmic · 104d
Cleared Aug 02, 1994
CVD SMALL VESSEL BALLOON DILATION CATHETER
K942150 · LIT
Cardio-Dynamics, Inc.
Cardiovascular · 91d
Cleared Aug 02, 1994
LOCKBOX
K942161 · FRN
Pharmacia Deltec, Inc.
General Hospital · 90d
Cleared Aug 02, 1994
SURGICAL LIFT SHEET
K942807 · FSA
Surgin Surgical Instrumentation, Inc.
General Hospital · 49d
Cleared Aug 02, 1994
ORVIS LIGHT WEIGHT POLARIZED CLIP-ONS
K942951 · HQY
The Orvis Co., Inc.
Ophthalmic · 40d
Cleared Aug 02, 1994
KINASE ISOENZYME
K943024 · JHS
Dupont Medical Products
Chemistry · 68d
Cleared Aug 02, 1994
FORCEPS, PUNCHES, SCISSORS
K943074 · EOB
KARL STORZ Endoscopy-America, Inc.
Ear, Nose, Throat · 35d
Cleared Aug 02, 1994
SPECTACLE FRAME
K943083 · HQZ
Pimex Co., Ltd.
Ophthalmic · 35d
Cleared Aug 02, 1994
SPECTACLE FRAME
K943086 · HQZ
Radiant Spectacles Manufacturers
Ophthalmic · 35d