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
92881–92904 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 03, 1997
ANTI-THYROGLOBULIN (TG) MICROPLATE ELISA
K971835 · DDC
Monobind
Immunology · 45d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P
K971865 · LDR
Alexander Mfg. Co.
General Hospital · 44d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS61010
K971866 · FLL
Alexander Mfg. Co.
General Hospital · 44d
Cleared Jul 03, 1997
LEVO ACTIVE-EASY LAE
K971873 · IPL
Levo USA
Physical Medicine · 44d
Cleared Jul 03, 1997
PEFECT SHOT
K972019 · EIA
International Imaging Electronics
Dental · 32d
Cleared Jul 03, 1997
STEALTH
K972036 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
PROWLER
K972037 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
INTRUDER
K972038 · INI
The Buzzz Corp.
Physical Medicine · 31d
Cleared Jul 03, 1997
NASAL SEPTAL BUTTON
K972060 · LFB
Boston Medical Products, Inc.
Ear, Nose, Throat · 31d
Cleared Jul 03, 1997
UNICAP SPECIFIC IGE FEIA ASSAY, LATEX ALLERGEN IMMUNOCAP K82
K972068 · DHB
Pharmacia, Inc.
Immunology · 30d
Cleared Jul 03, 1997
CUSTOM NASAL SPLINT
K972082 · LYA
Boston Medical Products, Inc.
Ear, Nose, Throat · 29d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M212
K972084 · FLN
Alexander Mfg. Co.
General Hospital · 29d
Cleared Jul 03, 1997
ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER MS06224
K972089 · MRZ
Alexander Mfg. Co.
General Hospital · 29d
Cleared Jul 01, 1997
QA-40M DEFIBRILLATOR TESTER
K963190 · DRL
Metron U.S., Inc.
Cardiovascular · 320d
Cleared Jul 01, 1997
HSV-1 ANTIGEN CONTROL SLIDES
K964874 · GQN
Viral Antigens, Inc.
Microbiology · 208d
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